Posts Tagged ‘Flexibility’

Accuray Gets 510(k) for CyberKnife M6 Series of Radiosurgery Machines

Accuray Gets 510(k) for CyberKnife M6 Series of Radiosurgery Machines

Accuray Gets 510(k) for CyberKnife M6 Series of Radiosurgery Machines

Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife® M6™ Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience. The new CyberKnife M6 FIM and FM Systems, featuring the InCise™ Multileaf Collimator combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery offering unmatched clinical capabilities and expanding the number of patients eligible for treatment.

The new InCise Multileaf Collimator was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical accuracy into a broader field of applications, meeting radiosurgery and radiotherapy needs. With the InCise Multileaf Collimator, the CyberKnife M6 Series can be used to treat large and irregular tumors more efficiently with excellent dose gradients. This added flexibility expands the number of patients eligible for treatment with the CyberKnife M6 Series.

“The CyberKnife M6 Series offers a collimation option to address a variety of clinical applications, including large, complex tumors. The InCise Multileaf Collimator is designed to sculpt a single radiation beam to match the exact contour of a tumor, which would significantly minimize the amount of radiation to the surrounding tissues and reduce the treatment time,” said Dwight Heron, M.D., Professor and Vice-Chairman, Radiation Oncology, Otolaryngology, Head & Neck Surgery at the University of Pittsburgh School of Medicine. “Now many targets previously unsuited for SRS/SBRT can be treated more quickly and effectively than before.”

Unlike any other MLC on the market, the InCise Multileaf Collimator can not only move its leaves to create complex shapes, it can also be moved around the patient by a robot in 3D to deliver precisely shaped beams to the target from hundreds of unique angles. This non-isocentric, non-coplanar delivery enables the highest level of accuracy and healthy tissue sparing. The added flexibility is further enhanced when combined with the CyberKnife’s Synchrony® System, which enables the CyberKnife M6 System to track tumors as they move and automatically correct for their movement throughout treatment.

“The field of radiation oncology is moving to treating in fewer fractions with higher doses,” said Charlie Ma, Ph.D., Vice Chairman, Department of Radiation Oncology, Director, Radiation Physics at the Fox Chase Cancer Center in Philadelphia. “The addition of the MLC, combined with the CyberKnife’s ability to deliver treatment from hundreds of angles while tracking and correcting for motion, will give us the flexibility to deliver the most accurate patient-specific and tailored dose distributions and allows a broader range of patients to benefit from highly efficient and effective treatments.”

The CyberKnife M6 Series reduces treatment times with fewer Monitor Units (MUs) while delivering unrivaled dose distributions and further improving plan quality. This heightened efficiency allows users to schedule more patients per day, to not only ensure timely care to more cancer patients, but to also improve the return on their investment.

“Accuray developed the CyberKnife M6 Series to provide the radiation oncology community with a personalized, patient-focused treatment that delivers unmatched clinical capabilities and the ability to treat more patients with unprecedented levels of precision and efficiency,” said Joshua H. Levine, president and chief executive officer of Accuray. “The development of the CyberKnife M6 Series addresses the needs of both physicians and patients, and reinforces Accuray’s position as the leading technical innovator driving new clinical solutions in radiation oncology.”

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company’s leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy, and adaptive radiation therapy. To date 642 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.

Safe Harbor Statement

Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to expansion of the Company’s global presence, clinical capabilities, treatment times, clinical efficiency, dose delivery, and the Company’s leadership position in radiation oncology innovation. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including risks detailed from time to time under the heading “Risk Factors” in the company’s report on Form 10-K filed on September 10, 2012. Forward-looking statements speak only as of the date the statements are made and are based on information available to the Company at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The Company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not place undue reliance on any forward-looking statements.

The CyberKnife System, the premier solution for full-body robotic radiosurgery, now extends its accuracy and precision to radiation therapy – allowing you the freedom to choose the very best treatment for each of your patients, with confidence and without compromise.

The CyberKnife® M6™ Series has the capabilities and efficiency required for every radiation oncology practice – for the treatments accepted today, as well as those of tomorrow. It is the only truly robotic system in the market, developed to meet the evolving needs of the most demanding radiation oncology programs.

Unmatched clinical excellence

Patient focused design

Capabilities to treat more patients and expand practice

With the new InCise™ Multileaf Collimator (optional on the FI version), the CyberKnife M6 Series is the only clinical solution to combine the benefits of MLC beam shaping with continual image guidance and non-isocentric, non-coplanar treatment delivery. Precisely sculpting dose to spare healthy tissue while maintaining sub-millimeter accuracy – even for targets that move during respiration – the CyberKnife M6 Series is the clinical solution when accuracy, flexibility, and efficiency are essential.

Created to make personalized treatments an option for your patients, the CyberKnife M6 Series offers a comprehensive set of clinical features. Indication-specific tumor tracking with automatic correction throughout treatment, true robotic mobility, and advanced collimation integrate seamlessly into the only system to automatically stay on target despite patient and tumor motion. Treat tumors anywhere in the body with confidence and without compromise.

Designed with the patient in mind, the CyberKnife M6 Series enhances patient comfort and improves the patient experience

Soothing environmental elements

Easy and efficient treatment

Frameless and non-invasive

Uniquely personalized treatments

The CyberKnife M6 Series introduces clinical capabilities not possible with other treatment systems. With the flexibility of the InCise™ Multileaf Collimator and robotic delivery, tumors previously thought untreatable with radiosurgery and SBRT can now be treated efficiently and with unrivaled accuracy and tissue sparing. You have the freedom to choose the very best treatment for each of your patients, expanding the field of radiosurgery with unmatched possibilities.

The CyberKnife M6 Series is available in three configurations:

The CyberKnife M6 Series

The CyberKnife M6 FIM System – Unmatched possibilities in full body robotic radiosurgery and radiation therapy

Advanced system geometry

Enhanced design

Fixed collimators

Iris™ Variable Aperture Collimator

InCise™ Multileaf Collimator

CNS clinical package

Prostate clinical package

Lung and prone clinical package

Clinical efficiency package

The CyberKnife M6 FM System – Advanced full-body robotic radiosurgery with added flexibility and efficiency

Advanced system geometry

Enhanced design

Fixed collimators

InCise Multileaf Collimator

CNS clinical package

The CyberKnife M6 FI System – The premier solution for full-body robotic radiosurgery

Advanced system geometry

Enhanced design

Fixed collimators

Iris Variable Aperture Collimator

CNS clinical package

The FDA cleared Accuray‘s CyberKnife M6 Series of devices that promise to expand the capabilities of radiosurgery.

The proprietary InCise Multileaf Collimator on the CyberKnife M6 FIM and FM systems is capable of changing its shape, and so the beam that it forms. The arm can approach the target tumor from just about any angle, providing flexibility for treatment planning.

From Accuray:

The new CyberKnife M6 FIM and FM Systems, featuring the InCise™ Multileaf Collimator combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery offering unmatched clinical capabilities and expanding the number of patients eligible for treatment.

The new InCise Multileaf Collimator was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical accuracy into a broader field of applications, meeting radiosurgery and radiotherapy needs.

With the new InCise™ Collimator (optional on the FI version), the CyberKnife M6 Series is the only clinical solution to combine the benefits of MLC beam shaping with continual image guidance and non-isocentric, non-coplanar treatment delivery. Precisely sculpting dose to spare healthy tissue while maintaining sub-millimeter accuracy – even for targets that move during respiration – the CyberKnife M6 Series is the clinical solution when accuracy, flexibility, and efficiency are essential.

Indication-specific tumor tracking with automatic correction throughout treatment, true robotic mobility, and advanced collimation integrate seamlessly into the only system to automatically stay on target despite patient and tumor motion.

Source : http://www.accuray.com/media/press-releases/accuray-receives-fda-510k-clearance-new-cyberknife%C2%AE-m6%E2%84%A2-series-merging-multilea

Full story

Accuray Gets 510(k) for CyberKnife M6 Series of Radiosurgery Machines

Accuray Gets 510(k) for CyberKnife M6 Series of Radiosurgery Machines

Accuray Gets 510(k) for CyberKnife M6 Series of Radiosurgery Machines

SUNNYVALE, Calif. November 1, 2012 – Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife® M6™ Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience. The new CyberKnife M6 FIM and FM Systems, featuring the InCise™ Multileaf Collimator combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery offering unmatched clinical capabilities and expanding the number of patients eligible for treatment.

The new InCise Multileaf Collimator was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical accuracy into a broader field of applications, meeting radiosurgery and radiotherapy needs. With the InCise Multileaf Collimator, the CyberKnife M6 Series can be used to treat large and irregular tumors more efficiently with excellent dose gradients. This added flexibility expands the number of patients eligible for treatment with the CyberKnife M6 Series.

“The CyberKnife M6 Series offers a collimation option to address a variety of clinical applications, including large, complex tumors. The InCise Multileaf Collimator is designed to sculpt a single radiation beam to match the exact contour of a tumor, which would significantly minimize the amount of radiation to the surrounding tissues and reduce the treatment time,” said Dwight Heron, M.D., Professor and Vice-Chairman, Radiation Oncology, Otolaryngology, Head & Neck Surgery at the University of Pittsburgh School of Medicine. “Now many targets previously unsuited for SRS/SBRT can be treated more quickly and effectively than before.”

Unlike any other MLC on the market, the InCise Multileaf Collimator can not only move its leaves to create complex shapes, it can also be moved around the patient by a robot in 3D to deliver precisely shaped beams to the target from hundreds of unique angles. This non-isocentric, non-coplanar delivery enables the highest level of accuracy and healthy tissue sparing. The added flexibility is further enhanced when combined with the CyberKnife’s Synchrony® System, which enables the CyberKnife M6 System to track tumors as they move and automatically correct for their movement throughout treatment.

“The field of radiation oncology is moving to treating in fewer fractions with higher doses,” said Charlie Ma, Ph.D., Vice Chairman, Department of Radiation Oncology, Director, Radiation Physics at the Fox Chase Cancer Center in Philadelphia. “The addition of the MLC, combined with the CyberKnife’s ability to deliver treatment from hundreds of angles while tracking and correcting for motion, will give us the flexibility to deliver the most accurate patient-specific and tailored dose distributions and allows a broader range of patients to benefit from highly efficient and effective treatments.”

The CyberKnife M6 Series reduces treatment times with fewer Monitor Units (MUs) while delivering unrivaled dose distributions and further improving plan quality. This heightened efficiency allows users to schedule more patients per day, to not only ensure timely care to more cancer patients, but to also improve the return on their investment.

“Accuray developed the CyberKnife M6 Series to provide the radiation oncology community with a personalized, patient-focused treatment that delivers unmatched clinical capabilities and the ability to treat more patients with unprecedented levels of precision and efficiency,” said Joshua H. Levine, president and chief executive officer of Accuray. “The development of the CyberKnife M6 Series addresses the needs of both physicians and patients, and reinforces Accuray’s position as the leading technical innovator driving new clinical solutions in radiation oncology.”

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company’s leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy, and adaptive radiation therapy. To date 642 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.

Safe Harbor Statement

Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to expansion of the Company’s global presence, clinical capabilities, treatment times, clinical efficiency, dose delivery, and the Company’s leadership position in radiation oncology innovation. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including risks detailed from time to time under the heading “Risk Factors” in the company’s report on Form 10-K filed on September 10, 2012. Forward-looking statements speak only as of the date the statements are made and are based on information available to the Company at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The Company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not place undue reliance on any forward-looking statements.

The CyberKnife System, the premier solution for full-body robotic radiosurgery, now extends its accuracy and precision to radiation therapy – allowing you the freedom to choose the very best treatment for each of your patients, with confidence and without compromise.

The CyberKnife® M6™ Series has the capabilities and efficiency required for every radiation oncology practice – for the treatments accepted today, as well as those of tomorrow. It is the only truly robotic system in the market, developed to meet the evolving needs of the most demanding radiation oncology programs.

Unmatched clinical excellence

Patient focused design

Capabilities to treat more patients and expand practice

With the new InCise™ Collimator (optional on the FI version), the CyberKnife M6 Series is the only clinical solution to combine the benefits of MLC beam shaping with continual image guidance and non-isocentric, non-coplanar treatment delivery. Precisely sculpting dose to spare healthy tissue while maintaining sub-millimeter accuracy – even for targets that move during respiration – the CyberKnife M6 Series is the clinical solution when accuracy, flexibility, and efficiency are essential.

Created to make personalized treatments an option for your patients, the CyberKnife M6 Series offers a comprehensive set of clinical features. Indication-specific tumor tracking with automatic correction throughout treatment, true robotic mobility, and advanced collimation integrate seamlessly into the only system to automatically stay on target despite patient and tumor motion. Treat tumors anywhere in the body with confidence and without compromise.

Designed with the patient in mind, the CyberKnife M6 Series enhances patient comfort and improves the patient experience

Soothing environmental elements

Easy and efficient treatment

Frameless and non-invasive

Uniquely personalized treatments

The CyberKnife M6 Series introduces clinical capabilities not possible with other treatment systems. With the flexibility of the InCise™ Multileaf Collimator and robotic delivery, tumors previously thought untreatable with radiosurgery and SBRT can now be treated efficiently and with unrivaled accuracy and tissue sparing. You have the freedom to choose the very best treatment for each of your patients, expanding the field of radiosurgery with unmatched possibilities.

The CyberKnife M6 Series is available in three configurations:

The CyberKnife M6 Series

The CyberKnife M6 FIM System – Unmatched possibilities in full body robotic radiosurgery and radiation therapy

Advanced system geometry

Enhanced design

Fixed collimators

Iris™ Variable Aperture Collimator

InCise™ Multileaf Collimator

CNS clinical package

Prostate clinical package

Lung and prone clinical package

Clinical efficiency package

The CyberKnife M6 FM System – Advanced full-body robotic radiosurgery with added flexibility and efficiency

Advanced system geometry

Enhanced design

Fixed collimators

InCise Multileaf Collimator

CNS clinical package

The CyberKnife M6 FI System – The premier solution for full-body robotic radiosurgery

Advanced system geometry

Enhanced design

Fixed collimators

Iris Variable Aperture Collimator

CNS clinical package

source : http://www.accuray.com/solutions/treatment-delivery/cyberknife/cyberknife-m6-series

Full story

Accuray’s New TomoTherapy H Series of Radiation Oncology Devices

Accuray’s New TomoTherapy H Series of Radiation Oncology Devices

Accuray’s New TomoTherapy H Series of Radiation Oncology Devices

SUNNYVALE, Calif. and ASTRO 2012 (Boston), October 28, 2012 – Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today launched its new TomoTherapy® H™ Series, featuring the TomoHDA™ System, with faster planning, faster delivery and increased quality. The TomoHDA System was unveiled at the 54th Annual American Society for Radiation Oncology (ASTRO) Meeting in Boston. Key features of the TomoHDA System include:

Accuray’s new TomoEDGE™ dynamic jaws technology provides users with added flexibility in treatment delivery by sharpening dose fall off and accuracy. In many cases the use of TomoEDGE for head and neck tumors and prostate cancer treatments has resulted in the reduction of beam-on time by half. With the TomoHDA™ System this new technology is standard and can be applied to both TomoHelical™ and TomoDirect™ treatment modes for 3DCRT and IMRT deliveries.

The high-performance VoLO™ Technology – an enhancement to the TomoTherapy® treatment planning system – leverages the new dose calculation algorithm and advanced graphics processing technology to increase clinical efficiency, throughput and flexibility in developing both simple and the most complex radiation therapy plans.

“We are committed to our TomoTherapy customers and continue to innovate to provide the most advanced treatments in radiation oncology with the goal of improving patient care,” said Joshua H. Levine, president and chief executive officer of Accuray. “The new TomoTherapy H™ Series offers treatment solutions for the entire spectrum of radiation therapy. It will enable unprecedented speed and efficiency ensuring the highest quality of care from the routine to the most complex cases.”

The TomoHDA System is a fully-integrated 3D image-guided, full spectrum radiation therapy system and builds upon the proven TomoTherapy Hi-Art® and TomoHD™ technologies. The TomoHDA System offers multiple new benefits including performance enhancements, unrivaled dose distributions and faster treatments.

The TomoHDA System is part of the new TomoTherapy H Series. Included in this series of products, is the new TomoH™ System, the gold standard for image-guided IMRT (intensity-modulated radiation therapy) treatment, providing streamlined 3D CT daily image guidance and ultrafast MLC (multileaf collimator) modulation, enabling the delivery of the dose to achieve excellent target homogeneity while sparing surrounding healthy tissue. Also included in the series is the TomoHD™ System – including TomoDirect – a full spectrum solution that provides high quality treatments to every patient for any clinical indication requiring radiotherapy.

The new TomoEDGE™ dynamic jaws are capable of sharpening the dose and allow customers to treat more patients with the TomoTherapy System. The jaws are optimized to sweep across the target, minimizing dose to healthy tissue and critical structures adjacent to the target and opening to the desired maximum size to reduce treatment time. The result is a balanced treatment delivery that is as unique as each patient.

Using the high-performance VoLO Technology, the TomoHDA™ system allows ultra fast creation of highly conformal treatment plans with the flexibility to design a personalized treatment plan specific to the individual needs of each patient. For example, the application of VoLO technology on breast cancer treatment plans has been shown to reduce dose calculation and treatment planning optimization time to as few as three minutes. TomoHDA also includes a fan-beam computed tomography (CT) system capable of producing images 50 percent faster, facilitating improved patient re-positioning time and therefore less overall time for the patient to be on the treatment couch.

“Having been involved in the creation of and research collaboration for the new TomoEDGE, we have seen firsthand that this is one of the most versatile radiation therapy treatment options available,” said PD Dr. Florian Sterzing, M.D., Consultant Radiation Oncologist at University Clinic of Heidelberg. “The new functionality enables improved quality of radiotherapy application and allows us to treat even more cancer patients.”

The TomoHDA System also includes Citrix®-based remote planning with web-based review capabilities, providing the ultimate flexibility for clinicians to develop and approve treatment plans from virtual workstations.

“TomoTherapy’s ability to treat the full range of disease sites, including even the most complex tumors, makes it an invaluable resource for cancer patients,” said Wade Gebara, M.D. Chief of Radiation Oncology at Berkshire Medical Center, Pittsfield, Mass. “With increased speed and reliability, the new TomoTherapy System will provide the opportunity for more patients to benefit from this personalized technology.”

Also on display in Accuray’s ASTRO booth (#7101) is the CyberKnife M6 FIM Sytem – part of the CyberKnife® M6™ Series – which is pending FDA 510(k) clearance and not yet available for commercial distribution in the United States. The new CyberKnife M6 FIM and FM Systems feature the InCise™ Multileaf Collimator, which combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery. The new InCise Multileaf Collimator (MLC) was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical precision into a broader field of applications. The system is intended to treat large and irregular tumors more efficiently with excellent dose gradients, to expand the number of patients eligible for treatment.

Researchers at Fox Chase Cancer Center in Philadelphia – who compared treatment plans created with a theoretical MLC on the CyberKnife System to those created originally with the CyberKnife Iris™ Collimator and conventional Intensity-Modulated Radiation Therapy (IMRT) plans – found that an MLC mounted on a robotic arm could potentially offer numerous clinical benefits, including faster treatment delivery, better target coverage and a sharper dose fall off could be achieved than a typical gantry- based IMRT plan or previous CyberKnife treatments. The Fox Chase researchers demonstrated the potential to create treatment plans that would spare critical structures around tumors better with a robotically mounted MLC, providing the ability to treat tumors using a higher dose without increasing the normal tissue toxicity.

Dates, times and locations of ASTRO clinical presentations featuring the CyberKnife and TomoTherapy Systems are available here.

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company’s leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy, and adaptive radiation therapy. To date 642 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.

Safe Harbor Statement

Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to expansion of the Company’s global presence, quality of treatments, accuracy, dose delivery, clinical efficiency, continual innovation, pending regulatory clearance, treatment times, dose sculpting, and the Company’s leadership position in radiation oncology innovation. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including risks detailed from time to time under the heading “Risk Factors” in the company’s report on Form 10-K filed on September 10, 2012. Forward-looking statements speak only as of the date the statements are made and are based on information available to the Company at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The Company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not place undue reliance on any forward-looking statements.

The TomoTherapy® System, the premier solution for the entire spectrum of radiation therapy — that delivers dose only where you need it — now with outstanding speed, performance and simplicity — allowing you the freedom to choose the very best treatment for each of your patients, with confidence and without compromise.

Created to make personalized treatments an option for radiation therapy, the TomoTherapy H Series offers interactive planning and efficient delivery of highly sculpted doses for personalized and consistent treatments. Seamless daily CT image guidance provides precise patient positioning, margin reduction and adaptive planning and enables pinpoint dose accuracy for every radiation therapy patient.

Clinical Excellence

Treats a full spectrum of radiotherapy patients without compromise

Enables planning and delivery of highly sculpted dose distributions

Patient Focus

Facilitates seamless daily CT image guidance for precise patient positioning, margin reduction and adaptive planning

Provides personalized and consistent treatments for every patient

Spares more normal tissue, helping to reduce side effects

Economic Impact

Schedule your radiation therapy patients in conventional time slots

Fast and flexible treatment planning for each individual patient

Automated quality assurance

The TomoTherapy H Series

The TomoHDA™ System – the ultimate flexibility in treatment delivery with unrivaled dose conformality, faster patient treatments, and faster concurrent treatment planning. It grants every patient access to high quality treatment

TomoEDGE™ spares more normal tissue while enabling increased throughput —with unprecedented quality

High performance VoLO™ planning provides flexibility, speed, efficiency and interactivity for concurrent treatment planning

Expand your practice by efficiently treating patients that are difficult to treat with conventional radiation therapy equipment

The TomoHD™ System – the full spectrum solution for any Radiation Oncology center, providing high quality treatments to every patient for any clinical indication requiring radiotherapy

TomoHelical™ and TomoDirect™ modalities to enable delivery of individualized treatments for both routine and complex indications

VoLO planning provides the ultimate in flexibility, speed and efficiency with real time interactive planning

The clinical solution when accuracy, flexibility and efficiency cannot be compromised

The TomoH™ System – the gold standard for image guided IMRT treatment delivery maximizes both conformality and target dose uniformity

CTrue™ image guidance provides daily 3D CT target localization and enables margin reduction while sparing healthy tissue

Ultra-fast binary MLC enables unprecedented intensity modulation

Excellent target homogeneity while sparing more normal healthy tissue

Accuray launched its new TomoTherapy H Series line of radiation oncology devices, headlined by the 3D image guided TomoHDA System with TomoEDGE technology. TomoEDGE optimizes radiation delivery by sharpening the affected edge between the target tumor and healthy tissue.

Accuray TomoTherapy H Series table Accurays New TomoTherapy H Series of Radiation Oncology Devices (VIDEO)

The company’s VoLO technology takes into account the new radiation dose delivery pattern into its calculations when doing graphic analysis in preparing treatment plans.

The three devices in the TomoTherapy H Series:

The TomoHDA™ System – the ultimate flexibility in treatment delivery with unrivaled dose conformality, faster patient treatments, and faster concurrent treatment planning. It grants everypatient access to high quality treatment

TomoEDGE™ spares more normal tissue while enabling increased throughput —with unprecedented quality

High performance VoLO™ planning provides flexibility, speed, efficiency and interactivity for concurrent treatment planning

Expand your practice by efficiently treating patients that are difficult to treat with conventional radiation therapy equipment

The TomoHD™ System- the full spectrum solution for any Radiation Oncology center, providing high quality treatments to every patient for any clinical indication requiring radiotherapy

TomoHelical™ and TomoDirect™ modalities to enable delivery of individualized treatments for both routine and complex indications

VoLO planning provides the ultimate in flexibility, speed and efficiency with real time interactive planning

The clinical solution when accuracy, flexibility and efficiency cannot be compromised

The TomoH™ System- the gold standard for image guided IMRT treatment delivery maximizes both conformality and target dose uniformity

CTrue™ image guidance provides daily 3D CT target localization and enables margin reduction while sparing healthy tissue

Ultra-fast binary MLC enables unprecedented intensity modulation

Excellent target homogeneity while sparing more normal healthy tissue

Source : http://www.accuray.com/media/press-releases/accuray-launches-new-tomotherapy%C2%AE-h%E2%84%A2-series-featuring-tomoedge%E2%84%A2

Full story

Dexcom G4 Platinum Continuous Glucose Monitor Cleared

Dexcom G4 Platinum Continuous Glucose Monitor Cleared

Dexcom G4 Platinum Continuous Glucose Monitor Cleared

New Device for Diabetes Management is Most-Advanced CGM Available with up to 30% Improvement in Hypoglycemic Accuracy

SAN DIEGO–(BUSINESS WIRE)– Dexcom (NASDAQ: DXCM), a leader in continuous glucose monitoring, announced today that the U.S. Food and Drug Administration has approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

“Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view,” said Terrance H. Gregg, Dexcom CEO. “The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance.”

Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years. The traditional standard-of-care for glucose (blood sugar) measurement has been a finger stick meter. Although they remain an essential part of a comprehensive diabetes management program, finger stick meters are inherently limited by the fact that, like a photograph, it only provides data for the specific moment in which the measurement is completed; it doesn’t show whether glucose is going up or down — or how fast.

By contrast, CGM provides an in-motion picture that shows not only glucose levels, but also the speed and direction in which it is moving, and alerts the user to sudden changes so they can take action.

The Dexcom G4 PLATINUM offers not only outstanding accuracy and performance, but many new capabilities, including:

Longest transmission range, enabling improved patient flexibility and convenience

A smaller, discrete profile that fits busy lifestyles

A first-of-its-kind color LCD display for easy viewing

Customizable alerts with specific tones

“Hypo alert” setting at 55 mg/dl that provides an increased level of safety — a feature that no other device has.

An ideal and convenient tool for diabetes management

The Dexcom G4 PLATINUM CGM system consists of just three parts: a sensor, transmitter, and monitor.

The tiny sensor – about the diameter of a human hair —is inserted by the user under the skin on the abdomen. A small transmitter sends data wirelessly to a sleek and small monitor, which easily fits in a purse or pocket. It provides data every 5 minutes for up to 7 consecutive days, quickly and easily showing the body’s response to medication, food and exercise. If users are outside their target zones, configurable alarms alert them so that they can take action.

The Dexcom G4 PLATINUM is prescribed by a physician and covered by most insurance plans for people taking insulin, and is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The company plans to begin taking orders for the Dexcom G4 PLATINUM immediately and expects to begin shipping to patients within the next several weeks. For more information, visit www.dexcom.com.

About Dexcom, Inc.

DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by patients with diabetes and by healthcare providers in the hospital.

Cautionary Statement Regarding Forward Looking Statements

DexCom is a medical device company with a limited operating history. Successful commercialization of the company’s products is subject to numerous risks and uncertainties, including a lack of acceptance in the marketplace by physicians and patients, the inability to manufacture products in commercial quantities at an acceptable cost, possible delays in the company’s development programs, the inability of patients to receive reimbursement from third-party payors and inadequate financial and other resources. Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company’s quarterly report on Form 10-Q for the period ended June 30, 2012, as filed with the Securities and Exchange Commission on August 6, 2012.

Amy Tenderich over at DiabetesMine is documenting her trial of the DexCom SEVEN, a continuous glucose monitor, that we initially covered back in 2005.

Dexcom (San Diego, CA) received FDA clearance for its G4 Platinum continuous glucose monitoring system. It includes an under-skin sensor, a wireless transmitter, and the interactive monitor that picks up readings from within 20 feet (6 meters).

This is a considerably improved device over their slightly older Seven Plus model, offering greater accuracy in trials, a significantly cooler look, and a new display that charts glucose levels and displays alerts.

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

dexcom transmitter Dexcom G4 Platinum Continuous Glucose Monitor Cleared in U.S. (video)The Dexcom G4 PLATINUM offers not only outstanding accuracy and performance, but many new capabilities, including:

Longest transmission range, enabling improved patient flexibility and convenience

A smaller, discrete profile that fits busy lifestyles

A first-of-its-kind color LCD display for easy viewing

Customizable alerts with specific tones

“Hypo alert” setting at 55 mg/dl that provides an increased level of safety – a feature that no other device has.

Source : http://investor.shareholder.com/dexcom/releasedetail.cfm?ReleaseID=711758

Full story

Ethicon’s New STRATAFIX Knotless Tissue Control Devices

Ethicon’s New STRATAFIX Knotless Tissue Control Devices

Ethicon’s New STRATAFIX Knotless Tissue Control Devices

ETHICON ANNOUNCES LAUNCH OF STRATAFIX™ KNOTLESS TISSUE CONTROL DEVICES

STRATAFIX™ Devices Transform Tissue Repair and Restoration Experience By Providing Surgeons Consistent Control and Performance

Somerville, NJ — October 4, 2012 /PRNewswire/ — Ethicon, Inc., a worldwide leader in surgical care, has announced its entrance into the barbed suture market with the launch of its new portfolio of STRATAFIX™ Knotless Tissue Control Devices, representing the next evolution in wound closure technology. With significantly more points of fixation than traditional sutures, STRATAFIX™ Devices give surgeons more consistent control over every pass (through the tissue), and combine the strength and security of interrupted closure with the efficiency of continuous closure.

The technical advancements of STRATAFIX™ Devices provide multiple clinical advantages for surgeons. The anchors running along the length of the device prevent it from loosening, making it easier for surgeons to control tension and maintain approximation, without assistance. The anchors also eliminate the need to tie knots, removing the possibility of knot-related complications and allowing surgeons to operate more efficiently. STRATAFIX™ Devices allow surgeons to close wounds substantially faster than when using an interrupted technique, meaning that patients also require less time under anesthesia.

For over a century, Ethicon has led technology advancements in surgical sutures and wound-closure devices. With the introduction of its new portfolio of STRATAFIX™ Devices, the company continues its tradition of innovation by bringing that trust, quality, and reliability to new surgical frontiers.

“The STRATAFIX™ portfolio paves the way for the development of entirely new surgical approaches that will transform the surgeon’s tissue repair and restoration experience, representing the future of wound closure,” says Tim Schmid, President, U.S. at Ethicon. “This product launch demonstrates our commitment to making investments in technology that will advance surgery. By utilizing Ethicon’s global reach and partnerships, we can bring the benefits of barbed suturing technology to more patients than previously possible.”

This fall, Ethicon will introduce STRATAFIX™ Spiral devices, the first products in the STRATAFIX™ portfolio. Additional products are expected to be available as early as next year as the portfolio is expanded.

About Ethicon

The Ethicon brand is used for the products of Ethicon, Inc. and Ethicon Endo-Surgery, Inc., two companies with long histories of medical innovation, which provide globally a broad range of surgical technologies and products (including sutures, staplers, clip appliers, trocars and meshes) used to treat colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. Ethicon, Inc. and Ethicon Endo-Surgery, Inc. are part of the Johnson & Johnson Family of Companies.

Ethicon, Inc., a division of J&J, is releasing its own line of barbed sutures that are designed to give surgeons more control and flexibility while maintaining the necessary strength to hold tissues together without using knots.

The STRATAFIX Knotless Tissue Control Devices feature barbs spaced 1mm apart spiraling along the length of the string that change direction midway down the suture. This provides surgeons the ability to create continuous and dual layer closures without using knots. Ethicon plans on kicking off the ilne with the release of STRATAFIX Spiral devices later this fall.

Source : http://www.multivu.com/mnr/58405-ethicon-launches-stratafix-knotless-tissue-control-devices

Full story

BIOTRONIK’s New Pulsar-35 Self-Expanding Stent and Passeo-14 PTA Balloon Catheter

BIOTRONIK’s New Pulsar-35 Self-Expanding Stent and Passeo-14 PTA Balloon Catheter

BIOTRONIK’s New Pulsar-35 Self-Expanding Stent and Passeo-14 PTA Balloon Catheter

BÜLACH, Schweiz, 14. September 2012 — Nach dem Erfolg des selbstexpandierenden Stentsystems Pulsar-18 von BIOTRONIK auf einer 0,018″/4F-Plattform hat das Unternehmen nun seine Pulsar-Stenttechnologie um eine 0,035″/6F-Plattform erweitert. Mit dieser bewährten Technologie und ihren vielversprechenden klinischen Leistungswerten baut BIOTRONIK sein heute schon umfassendes Stentportfolio aus und stellt dadurch noch mehr Ärzten seine qualitativ hochwertige Technologie zur Verfügung.

Das Pulsar-Stentsystem wurde im Rahmen der klinischen Studie 4EVER untersucht. Diese bestätigt eine primäre Offenheitsrate nach sechs Monaten von 90 Prozent. Die Ergebnisse dieser Studie wurden im Januar 2012 auf dem Leipzig Interventional Course (LINC) von Studienleiter Dr. Marc Bosiers, Chefarzt der Abteilung für Gefäßchirurgie an der Klinik AZ Sint Blasius in Dendermonde, Belgien, vorgestellt.

Bei 4EVER handelt es sich um eine prospektive, nicht-randomisierte, multizentrische klinische Studie mit 120 Patienten, bei der die Sicherheit und Wirksamkeit von Pulsar-Stents in der Oberschenkelarterie (Arteria femoralis superficialis) evaluiert wird. Die Studie untersucht sowohl die kurz- als auch die langfristige Leistungsfähigkeit von 4F-kompatiblen Stents. Der Endpunkt ist die primäre Offenheitsrate nach 12 Monaten. Als sekundäre Endpunkte werden der technische Erfolg, die Zeit bis zur Blutstillung (Hämostase) und die Wundkomplikationsrate beurteilt.

Die Sechs-Monats-Ergebnisse der 4EVER Studie zeigen folgende Highlights: primäre Offenheitsrate in 90 % der Fälle; kein Auftreten einer Revaskularisierung des Zielgefäßes (target lesion revascularization, kurz TLR) in 95,4 % der Fälle; technischer Erfolg in 100 % der Fälle und eine durchschnittliche manuelle Komprimierungszeit von 8,12 Minuten (keine Verwendung von vaskulären Verschluss-Systemen).

Die vielversprechenden Resultate der 4EVER Studie veranschaulichen die großen technischen Erfolgschancen der 4F-Intervention und die klinische Leistungsfähigkeit des Pulsar-Stentsystems von BIOTRONIK. Die vollständigen 12-Monats-Ergebnisse der 4EVER Studie werden im September 2012 auf dem CIRSE Annual Congress and Postgraduate Course (CIRSE 2012) in Lissabon (Portugal) vorgestellt.

In dem selbstexpandierenden Stentsystem Pulsar-35 vereint BIOTRONIK seine bewährte Technologie mit einem innovativen Kathetersystem. Pulsar 35 beinhaltet ein dreiachsiges Trägersystem zur Unterstützung einer präzisen Implantation. Das System verfügt über dieselbe Stentkonstruktion wie Pulsar-18, einschließlich Eigenschaften wie der hohen axialen Flexibilität und der optimierten Radialkraft, die besonders für die Herausforderungen der Stentimplantation in der Arteria femoralis superficialis geeignet sind. Mit seinen verfügbaren Längen von 30 mm bis 200 mm und Durchmessern zwischen 5 mm und 7 mm bietet Pulsar 35 erweiterte Behandlungsoptionen mit vielversprechenden klinischen Daten.

Kürzere Eingriffszeit mit BIOTRONIK Ballonkatheter Passeo-14

BIOTRONIK erweitert sein Produktportfolio für die vaskuläre Intervention der unteren Gliedmaße mit dem Passeo-14. Dies ist ein spezieller 0,014″ Ballonkatheter für die perkutane transluminale Angioplastie (PTA) der infrapoplitealen Arterien. Er wurde in Zusammenarbeit mit Experten für infrapopliteale Eingriffe entwickelt und verfügt über Eigenschaften, die besonders dazu geeignet sind, die bekannten Schwächen von herkömmlichen infrapoplitealen PTA-Kathetern zu beheben. Zu den wichtigsten Produkteigenschaften gehören ein versteifter proximaler Katheterschaft und eine hydrophile Beschichtung für eine exzellente Vorschubfähigkeit und Passierfähigkeit, zusätzlich eine speziell auf den Ballondurchmesser abgestimmte distale Schaftlänge, die optimale Flexibilität in stark gewundenen Gefäßanatomien bietet. Durch die verfügbaren Ballonlängen von bis zu 220 mm kann dieser Katheter dazu beitragen, die Eingriffszeit zu verkürzen und die Notwendigkeit von mehrfachen Inflationsvorgängen zu verringern.

„Mit dem Pulsar-35 Stentsystem und dem Passeo-14 PTA-Ballonkatheter kann BIOTRONIK nun noch besser auf die Bedürfnisse der Ärzte eingehen und bietet nicht nur die beste Technologie der Branche, sondern auch vielfältige Behandlungsoptionen“, erklärt Alain Aimonetti, Vize-Präsident Vertrieb und Marketing, BIOTRONIK Vaskuläre Intervention. „Unsere solide Produktpipeline und klinische Studien werden BIOTRONIK zu einem führenden Unternehmen auf dem Gebiet der peripheren vaskulären Innovationen machen. Die neuesten Entwicklungen und aktuellsten Studien von BIOTRONIK unterstreichen die Stärke und Leistungsfähigkeit unseres einzigartigen Produktportfolios für die unteren Gliedmaße und unser kompromissloses Engagement für technologische Spitzenleistungen.“

Über BIOTRONIK SE & Co. KG

Als einer der weltweit führenden Hersteller kardiovaskulärer Medizintechnik ist BIOTRONIK mit mehr als 5.600 Mitarbeitern in über 100 Ländern präsent. Mit Millionen implantierten Produkten tragen wir dazu bei, Lebensqualität zu verbessern und Leben zu retten. Wir verstehen uns als Partner der Ärzte und des medizinischen Fachpersonals. Wir analysieren die Herausforderungen, denen Ärzte gegenüberstehen und bieten ihnen die besten Lösungen für alle Phasen der Patientenbetreuung, von der Diagnose über die Behandlung bis hin zum Patientenmanagement. Unsere Markenzeichen sind Qualität, Innovation und Zuverlässigkeit. Darauf beruht der wachsende Erfolg von BIOTRONIK. Ärzte und Patienten weltweit schenken uns ihr Vertrauen, wir geben ihnen Sicherheit.

Pulsar-35

The Pulsar-35 system features the clinically proven »Pulsar stent« with its high multi-axis flexibility and optimized radial force considered necessary to meet the demands of SFA stenting.

Release handle

Allows one handed smoother, controlled, accurate stent placement. This aims to avoid stretched or compressed stent implantation.

Longer stent lengths

For treating lesions up to 190 mm in both SFA and BTK without overlapping.

Optimized radial force

Incremental increase of radial force compared to Astron Pulsar without compromising flexibility

Tri-axial catheter

Isolates retractable catheter from friction caused by introducer valve, aimed at ensuring precision-like implantation accuracy.

Questions regarding this product?

Please fill out the contact form with your request for additional information, and you will receive an answer within 24 hours.

Press release

BIOTRONIK Launches Pulsar-35 Self-Expanding Stent and Passeo-14 PTA Balloon Catheter

Best-in-class technology with flexibility for different treatment options

BUELACH, Switzerland, September 14th, 2012 — Following the success of BIOTRONIK’s Pulsar-18 0.018″/4F-platform self-expanding stent system, the company has now introduced its Pulsar stent technology in a 0.035″/6F platform. With this BIOTRONIK is offering even more physicians its high qualitative stent technology with its high technical success and encouraging clinical performance.

Pulsar stent technology was proven effective during the 4EVER clinical study, with six-month clinical patency rates of 90%. Results were presented in January 2012 at The Leipzig Interventional Course (LINC), Germany, by principal investigator Dr. Marc Bosiers, Chief of Surgery, AZ Sint Blasius, Dendermonde, Belgium.

The 4EVER study is a prospective, nonrandomized, multicenter, 120-patient clinical investigation that evaluates the safety and efficacy of Pulsar stents in the superficial femoral artery (SFA). It examines both the acute and long-term performance of 4F-compatible devices. The primary endpoint is primary patency at 12 months, with secondary endpoints being technical success, time to hemostasis and wound complication rate.

Six-month highlights from 4EVER study data include: primary patency, 90%; freedom from target lesion revascularization (TLR), 95.4%; technical success, 100%; and mean manual compression time, 8.12 minutes (no vascular closure devices used).

The promising 4EVER study data demonstrate the high technical success possible with 4F intervention and the encouraging clinical performance of BIOTRONIK’s Pulsar stent systems. Full 12-month data from the 4EVER study will be announced at the CIRSE Annual Congress and Postgraduate Course (CIRSE 2012) in Lisbon, Portugal, in September 2012.

The addition of the Pulsar-35 self-expanding stent system will make BIOTRONIK’s proven stent technology available to even more clinicians offering a convenient platform. The Pulsar-35 features a triaxial delivery system designed to provide precise implantation accuracy, and the system benefits from the same outstanding stent design as the Pulsar-18—including features such as high multiaxis flexibility and optimized radial force specifically designed for the challenges of SFA stenting. Available in lengths from 30 mm to 200 mm and diameters of 5 mm to 7 mm, this stent will provide an additional treatment option with promising clinical data.

BIOTRONIK Passeo-14 balloon catheter may shorten procedure time

Joining the Pulsar-35 in BIOTRONIK’s evolving lower limb portfolio is the Passeo-14 balloon catheter, a dedicated 0.014″ infrapopliteal percutaneous transluminal angioplasty (PTA) catheter. Developed in collaboration with infrapopliteal experts, the device’s unique features are designed to address weaknesses common to infrapopliteal PTA catheters. Key features include a stiffened proximal catheter shaft and hydrophilic coating for excellent push transmission and crossability—plus a balloon-diameter-specific distal shaft length that provides optimized flexibility in tortuous pedal anatomy. Available in balloon lengths of up to 220 mm, this device may shorten procedure times and could reduce the need for multiple inflations.

“The Pulsar-35 self-expanding Stent and Passeo-14 PTA balloon catheter greatly improve BIOTRONIK’s ability to meet physician needs and deliver best-in-class technology with flexibility for different treatment options,” said Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention. “Our robust product and clinical pipeline will continue to make BIOTRONIK a leader in peripheral vascular innovations, and these latest clinical and product developments underscore the strength and performance of BIOTRONIK’s unique lower limb portfolio and our continuing commitment to delivering technological excellence backed by scientific evidence.”

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

BIOTRONIK is launching its Pulsar-35 Self-Expanding Stent, a 6 French sized system, and the matching Passeo-14 PTA Balloon Catheter.

BIOTRONIK Passeo 14 BIOTRONIKs New Pulsar 35 Self Expanding Stent and Passeo 14 PTA Balloon CatheterThe Pulsar-35 is based on the popular Pulsar stent that provides high multi-axis flexibility and can be positioned using one handed operation by the surgeon.

Some details about the new devices:

The Pulsar-35 features a triaxial delivery system designed to provide precise implantation accuracy, and the system benefits from the same outstanding stent design as the Pulsar-18—including features such as high multiaxis flexibility and optimized radial force specifically designed for the challenges of SFA stenting. Available in lengths from 30 mm to 200 mm and diameters of 5 mm to 7 mm, this stent will provide an additional treatment option with promising clinical data.

Joining the Pulsar-35 in BIOTRONIK’s evolving lower limb portfolio is the Passeo-14 balloon catheter, a dedicated 0.014? infrapopliteal percutaneous transluminal angioplasty (PTA) catheter. Developed in collaboration with infrapopliteal experts, the device’s unique features are designed to address weaknesses common to infrapopliteal PTA catheters. Key features include a stiffened proximal catheter shaft and hydrophilic coating for excellent push transmission and crossability—plus a balloon-diameter-specific distal shaft length that provides optimized flexibility in tortuous pedal anatomy. Available in balloon lengths of up to 220 mm, this device may shorten procedure times and could reduce the need for multiple inflations.

Source : http://www.biotronik.com/wps/wcm/connect/int_web/biotronik/newsroom/press_releases?p=

http://www.biotronik.com/wps/wcm/connect/int_web/biotronik/newsroom/press_releases/pr_cirse_2012_en&pw=770&pt=

Full story

A Jet Tour of Northeast Indiana’s Medical Device Hub

A Jet Tour of Northeast Indiana’s Medical Device Hub

A Jet Tour of Northeast Indiana’s Medical Device Hub

This past week, Medgadget was invited to take a tour of Northeast Indiana, a region of ten counties surrounding and encompassing the city of Fort Wayne. You might already know about Warsaw, about 30 miles from Fort Wayne, as the headquarters for DePuy, Biomet, Zimmer, and a number of other companies that make the city the leading orthopedic device leader in the world. However, the rest of Northeast Indiana has also been evolving into a thriving medical device manufacturing hub, as labor is available, land is plentiful, and the region is very open and friendly toward the medical device manufacturing industry. In fact, according to the Northeast Indiana Regional Partnership, our host for the two day tour, the region has consistently been a leader in terms of dollars invested and jobs created in the industry. Over two days, we toured a number of different companies and talked to a number of executives about what makes their businesses successful and why they’re at a good place being in Northeast Indiana.

Micropulse offices A Jet Tour of Northeast Indianas Medical Device HubOur first stop was Micropulse, a contract manufacturer of implants and instruments for a number of large medical device clients. Micropulse was originally founded to produce parts for the automotive industry, but in the early 2000?s, founder and CEO Brian Emerick saw his business growing stagnant, and so he switched to medical devices and has Iotron A Jet Tour of Northeast Indianas Medical Device Hubnever looked back since. What’s interesting about Micropulse is that its facilities are also headquarters to the OrthoVation Center, a new incubator for Emerick’s other medical product ventures. The OrthoVation Center currently is home to four companies: Del Palma Orthopedics, Nanovis, BioSpine, and Sites Medical.

The next stop on our tour was a company that uses state-of-the-art technology to sterilize medical devices and other products. Vancouver-based Iotron recently opened a $15 million sterilization facility in the area and wanted to show us around.

Unlike current sterilization technologies that use gamma radiation or ethylene oxide gas, Iotron uses an electron beam for irradiation, which allows for much faster processing and greater flexibility in terms of applications, which in turn leads to lower cost for both the company and client. Electron beam technology also causes less material degradation compared to gamma radiation.

Our tour included a cool look at the electron beam generator and emitter (pictured), which is housed in the maze-like “shield”. Pretty cool stuff.

Precision Medical Technologies A Jet Tour of Northeast Indianas Medical Device HubNext, we traveled to Warsaw to visit Precision Medical Technologies, another contract manufacturer of orthopedic implants and surgical instruments. PMT has been extremely successful and is building another facility to handle their instrument manufacturing division in a neighboring county. Much of PMT’s success can be attributed to investing money in expensive, yet more sophisticated machinery that reduces the number of steps that it takes to manufacture a part, resulting in fewer variances and greater productivity. PMT also works very closely with local high schools and colleges to develop talented and experienced individuals to support the industry in the region.

Next was LH Medical, a division of LH Industries, which manufactures parts for a number of different types of businesses. Their medical division was started only about five years ago and has seen great success. Part of their vision is to manufacture all the parts that the other companies feel are too difficult or too low volume to manufacture. LH Medical also has its own team of design engineers to assist their clients in refining the design and manufacturing process.

Notre Dame Innovation Park A Jet Tour of Northeast Indianas Medical Device HubOur last stop was the campus of the University of Notre Dame to visit Innovation Park, an organization that provides facilities, funding, and other support for startups in life sciences and other industries. We had the opportunity to learn about some of the life science startups currently housed within their beautiful, new facility overlooking the Fighting Irish athletic complexes. CareX, founded by a Notre Dame management professor, is developing web-based point-of-care systems for physicians, caregivers, and extended/assisted living home nurses to track changes in their patients’ health. Altapure A Jet Tour of Northeast Indianas Medical Device Hub

Altapure, whose device we wrote about back in February, has developed a room/area sterilizer using ultrasonic technology to produce a highly dense cloud of liquid that can eliminate dangerous pathogens. F Cubed is developing and commercializing lab-on-chip technology to rapidly detect the DNA of dangerous bacteria in recreational and drinking water, food, and human fluid samples.

Overall, we got the sense that there’s a lot of innovation in the region, and we’re optimistic that, given the high rate of growth in the area, Northeast Indiana will join the ranks of the major medical hubs in the U.S.

Source : http://www.neindiana.com/

Full story

Covidien’s LigaSure Small Jaw Instrument Now for Open ENT Procedures

Covidien’s LigaSure Small Jaw Instrument Now for Open ENT Procedures

Covidien’s LigaSure Small Jaw Instrument Now for Open ENT Procedures

BOULDER, Colo.–(BUSINESS WIRE)–Sep. 11, 2012– Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures. When working in confined surgical spaces, the proprietary LigaSure device addresses surgeons’ needs by offering a low-temperature profile and minimal thermal spread to surrounding tissues.

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, l …

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s hands. (Photo: Business Wire)

The new clearance, for the device’s use in head and neck procedures, will allow for additional uses such as thyroidectomies, parotidectomies and additional open ENT procedures. There are more than 160,000 of these procedures performed each year in the United States. The LigaSure small jaw instrument, sold worldwide, was previously cleared for use in general surgery by the FDA in February 2011.

“This is a major milestone in recognizing the LigaSure small jaw instrument as an effective open surgical device and significantly expands its use throughout the surgical community. We believe surgeons will see it as a valuable tool for ENT procedures,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “LigaSure technology has set the industry standard in vessel sealing since 1998. This technology has been used in millions of surgical procedures worldwide and is supported by an every growing body of evidence-based research.”

LigaSure’s features received positive comments from surgeons during development as well as post-commercialization. “I confidently placed my finger immediately adjacent to the tips while sealing without feeling any significant heat,” said Dr. Thomas P. Rauth, a surgeon at Vanderbilt University Medical Center. “The importance of this cannot be stressed enough.” He also praised the device’s functionality, stating that “the ergonomics of the device are outstanding. The hand activation with the closing of the instrument is a simple, yet brilliant, concept. It sped up the operation since I didn’t have to search for a foot control or second button to activate the current.1”

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s hands. Its multifunctional design also provides for blunt dissection and an enhanced experience for the surgeon, especially in confined surgical spaces. LigaSure technology, powered by the ForceTriad™ energy platform, gives surgeons a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls.

The product will be showcased this year at the American College of Surgeons Annual Clinical Congress, to be held September 30 – October 4 in Chicago, IL. Surgeons are invited to booth 1819 to further explore the benefits of the LigaSure small jaw instrument.

Overview

Sealer/divider

Hand or foot activation

Fuses vessels, including pulmonary vasculature, up to and including 7 mm in size, lymphatics and tissue bundles

Approximately 2 to 4 second seal cycle

May reduce the exchange of instruments compared to mechanical ligation

Compatible with the ForceTriad™ energy platform only, v 3.4 or greater

Procedures

General procedures

Plastic/reconstructive procedures

Urologic procedures

Thoracic procedures

Covidien has received 510(k) clearance from the FDA for the firm’s LigaSure Curved, Small Jaw, Open Sealer/Divider, a device used in general surgery. It will be available in the US later this quarter.

The LigaSure Curved, Small Jaw, Open Sealer/Divider, the newest addition to the LigaSure family of advanced surgical cutting/sealing devices, provides an integrated cutting mechanism independent of sealing, leaving the critical cutting decisions in the hands of the surgeon. Its multi-functional design also provides for blunt dissection and an enhanced, more efficient experience for the surgeon, especially in confined surgical spaces. A primary feature of this new LigaSure device is a low-temperature profile and minimal thermal spread to surrounding tissues.

The proven LigaSure technology, powered by the ForceTriadTM energy platform, provides surgeons with a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls.

Source : http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1733818&highlight=

Full story

MEDICAL-GRAD 3D MONITOR

MEDICAL-GRAD 3D MONITOR

PANASONIC INTRODUCES 32” MEDICAL-GRADE 3D MONITOR FOR THE SURGICAL SUITE

Monitor Delivers 3D and 2D Image Quality, Flexibility, Functionality and Reliability to the Operating Room

Secaucus, NJ, July 11, 2012 – Panasonic, a provider of professional healthcare display and monitor solutions, today announced a new 3D medical-grade 32” class monitor, the EJ-MDA32U-K. The new 3D monitor is fully compliant with medical equipment standards, delivers exceptional 2D and 3D image quality and can display multiple images from various sources at once. These combined features, paired with Panasonic’s renowned reliability, make the new monitor ideal for use in the surgical bubble.

“To improve patient outcomes, there is an ever increasing reliance on technology in the surgical suite,” said Scott Thie, Director, Healthcare, Panasonic System Communications Company of North America. “Although this technology has many benefits, it can also create a cluttered environment. The EJ-MDA32U-K helps to improve the surgical experience by having a large screen, HD image that can be clearly viewed by all clinicians, while also providing flexibility that helps to reduce clutter. By allowing up to three images to be displayed on the screen at once – from multiple input sources – and by delivering high quality 3D and 2D HD images, we offer a single device that addresses multiple needs in the surgical suite.”

3D Experience

The Xpol® circular polarizing system used in the EJ-MDA32U-K offers several advantages over linear polarization solutions. Panasonic’s passive circular polarizing glasses and the Xpol® system maintain the stereoscopic effect even when the head is tilted to the left or right – a vital benefit linear polarization solutions cannot offer. This feature enables a natural viewing experience allowing several clinicians or medical students in the O.R. to watch the same 3D display. For increased flexibility, the device also supports multiple 3D formats and inputs.

Healthcare

Designed for the Surgical Suite

The EJ-MDA32U-K allows for up to three images, from three separate sources, to be displayed simultaneously, on one screen. The monitor supports two HD-SDI inputs, two DVI inputs and an analog input. This allows live viewing of the surgical procedure, radiological images and vital signs on a single display. This multi-function viewing capability helps reduce clutter and cabling in the surgical suite.

The EJ-MDA32U-K is fully compliant with medical equipment standards, including FDA Class 1 and UL60601-1 certification, and is additionally IPX1Protection rated with an antimicrobial surface making it easy to clean and sanitize.

Exceptional Image Quality

IPS-Pro Panel technology enables natural full HD images to be viewed from a wide selection of angles such as top, bottom, left and right. IPS-Pro also reproduces vibrant color, stereoscopic effect and perspective.

The 32” class (1,920 x 1,080) medical-grade monitor produces HD images with over 2 million pixels and a 1200:1 contrast ratio, delivering the superb image quality needed in surgical settings. The EJ-MDA32U-K’s exceptional color reproduction and user-friendly technology also reduces eye fatigue when viewing content in 3D or 2D.

Panasonic’s EJ Family of Medical-Grade Monitors

The EJ-MDA32U-K is the first 3D capable monitor in the EJ medical grade monitor line that currently includes a 2D 26” class monitor, the EJ-MLB26U-W, a 2D 32” class monitor, the EJ-MLA32U-W, and a 2D 37” class monitor, the EJ-MLA37U-W. Panasonic now offers a family of full HD medical grade monitors with vibrant color and stereoscopic effect that surpass medical electrical equipment sanitization and industry standards and allow for simultaneous viewing of multiple images.

Select Features and Specifications for the Panasonic EJ-MDA32U-K*:

  • LCD Panel: 32 inch (16:9 aspect ratio)
  • Screen Dimensions: 698mm (27.5”) (W) x 393mm (15.5”) (H)801 mm (31.5”) (Diagonal)
  • Number of pixels: 2,073,600 pixels (1,920 x 1,080)
  • Viewing angle: Horizontal: 178° Vertical: 178° (at 2D mode CR>10)
  • Contrast: 1200:1
  • Luminance: 340cd/m2 (typ.)
  • Number of colors: 16.77 Million (8bit)
  • Display modes: Dual display mode / Triple display mode / PIP and POP modes / Mirror image mode
  • Mounting: 200mm VESA
  • Certification: UL60601-1, IEC60601-1-2 ,FCC 47 CFR Part 15, Subpart B Class A
  • 3D Format: SIMUL (Dual input) / Line-by-Line / Side-by-Side / Top & Bottom
  • 3D Input: HD-SDI / DVI-D
  • 3D viewer: 3D polarized eyewear (3 pairs supplied)

*Specifications subject to change without notice

Pricing and Availability

The EJ-MDA32U-K is available at a suggested list price of $14,500 from authorized Panasonic System Communications Company of North America (PSCNA) resellers and distributors.

Sales inquiries for Panasonic’s EJ-MDA32U-K should be directed to Manny Desai at manish.desai@us.panasonic.com or 201-392-6839.

Follow Panasonic Solutions for Business Blog

The Panasonic for Business Blog delivers insights and opinions about the technology and related issues directly impacting business and government today and discusses how leading organizations can better acquire, manage and interpret information in order to drive innovation.

For more information on Panasonic’s healthcare solutions go to

Panasonic Solutions for Business

Built on a celebrated engineering foundation, Panasonic architects business technology solutions that help build a better world. Customers in government, healthcare, production, education and a wide variety of commercial enterprises, large and small, depend on integrated solutions from Panasonic to help them acquire, manage and interpret the information that drives innovation. The complete suite of Panasonic solutions addresses unified business communications, mobile computing, security and surveillance, retail point-of-sale, office productivity, high definition visual conferencing, visual communications (professional projectors, displays, digital signage) and HD and 3D video production. As a result of its commitment to R&D, manufacturing and quality control, Panasonic engineers reliable and long-lasting solutions as a partner for continuous improvement. Panasonic solutions for business are delivered by Panasonic System Communications Company of North America, which is a division of Panasonic Corporation of North America, the principal North American subsidiary of Panasonic Corporation (NYSE: PC).

All brand and company/product names are trademarks or registered trademarks of the respective companies. All specifications are subject to change without notice. Information on Panasonic solutions for business can be obtained by calling 877-803-8492 or at http://www.panasonic.com/business-solutions/.

About Panasonic Corporation of North America

Based in Secaucus, NJ, Panasonic Corporation of North America provides a broad line of digital and other electronics products and services for consumer, business and industrial use. The company is the principal North American subsidiary of Osaka, Japan-based Panasonic Corporation (NYSE: PC), and the hub of Panasonic’s U.S. branding, marketing, sales, service and R&D operations. Panasonic was the only Consumer Electronics company to be listed in the top ten brands on the Interbrand Best Global Green Brands 2011 ranking (http://www.interbrand.com/en/best-global-brands/Best-Global-Green-Brands/2011-Report/BestGlobalGreenBrandsTable-2011.aspx). As part of its continuing efforts to reduce its carbon footprint, Panasonic Corporation of North America will relocate its operations to a new eco-efficient office tower adjacent to a mass transit hub in Newark, NJ in 2013. Information about Panasonic Eco Ideas initiatives is available at http://panasonic.net/eco/ecoideas/. Information about Panasonic and its products is available at www.panasonic.com. Additional company information for journalists is also available at www.panasonic.com/pressroom.

Source : http://www2.panasonic.com/webapp/wcs/stores/servlet/prModelDetail?storeId=11301&catalogId=13251&itemId=681504&modelNo=Content07122012125420173&surfModel=Content07122012125420173

Related Posts Plugin for WordPress, Blogger...

Full story

Copyright © 2018 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes