Archive for ‘surgery’

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Cambridge Medical Robotics Shows Off Its New Versius System

Cambridge Medical Robotics Shows Off Its New Versius System

versius

 

Cambridge Medical Robotics, a UK firm, is revealing its Versius robotic surgery system. The system consists of modular robotic arms, any number of which can be used depending on a procedure. The arms can have a camera or any one of the dozen or so tools attached, and they can be quickly swapped for other tools as necessary.

Each of the arms can be placed around the patient table or even hung from above to save valuable space. The surgeon wears a pair of 3D glasses and operates by looking at a monitor instead of peering into a scope common on existing systems. This can help improve ergonomics and allow the surgeon to see and interact easier with clinicians managing the patient and the robot. The robot is operated using a controller similar to video game joysticks and the system delivers haptic feedback from the instrument to the controller, so the surgeon can actually feel the anatomy being worked on.

Unlike existing robotic surgical systems, the Versius can work with instruments requiring only a 5 mm incision. Typically the smallest instrument sizes on robotic systems is 8 mm, and unlike 5 mm incisions these typically require suturing and maintenance.

The company has already performed a number of studies, including on cadavers, and is compiling responses and data from 32 surgeons that has already used the Versius system. The firm hopes to receive the CE Mark in Europe in 2018 and FDA regulatory green light shortly thereafter.

More info from CMR…

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SurgVision Displays Tumors During Surgery

SurgVision Displays Tumors During Surgery

surgvision-device

 

At RSNA 2016 in Chicago, SurgVision, a Dutch firm, was showing off its intra-surgical molecular probe fluorescence imaging system designed for excising hard to spot tumors. The system relies on novel dyes attached to tumor-seeking antibodies and a multi-spectral fluorescence imaging camera to spot the dye within tissue.

The imaging system uses multiple cameras and an array of LEDs, both near-infrared and white light ones, to differentiate between normal tissue and tissue that has a concentration of the dye present. Near-infrared light is used to excite the dye and to produce fluorescence that the cameras can see. White light is used to capture the field of view in order to overlay the location of the tumor on top of it.

The system does not actually project what it’s seeing onto the anatomy, so the surgeon has to look at a screen. In the future, though, projection could be integrated or another solution, such as a Microsoft HoloLens, used so that the location of the tumor appears right on top of the actual anatomy.

There’s also work on one day using this technology for photodynamic therapy, but that would require a dual-labeled marker that would fluoresce when excited by one wavelength of light and heat up when illuminated by another.

Though the company is Dutch, it’s a spinoff of the Technical University of Munich. They hold a number of patents for their technology, and are looking to bring their imaging device and matching tracer to market sometime within the next couple of years. The company has already done six clinical trials, of which two have been fully completed, and half a dozen papers have already been published. The SurgVision is available for clinical research, but in the U.S. there still needs to be a Phase III 510(k) clinical trial for it to receive clearance for clinical use.

surgvision-example

Sample images taken with the SurgVision Explorer Air for a peritoneal metastasis case. a) White-light imaging b) Near infrared fluorescence image c) The white light image overlain with the NIRF image

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iBreastExam: Low Cost, Point-of-Care Breast Health Test

iBreastExam: Low Cost, Point-of-Care Breast Health Test

ibreastexam

 

UE Lifesciences, a company with offices in the U.S. and India, has developed the iBreastExam, a low-cost point-of-care breast health test for use by community workers in low resource settings. This device is designed to address the rising incidence of breast cancer in developing countries where women have limited or no access to breast cancer screening services. UE Lifesciences have featured on Medgadget previously, for their NoTouch BreastScan, an infrared scanner to detect breast cancer for use in a conventional clinical setting. However, the iBreastExam is their first point-of-care wireless scanner, designed to be highly portable and easy to use.

The test is painless and radiation free, and takes less than 5 minutes to complete. The device can be used by any doctor or health worker and the results are available at the point-of-care. iBreastExam assesses differences in tissue elasticity between malignant and non-cancerous breast tissue, and its tactile sensor measures shear stiffness and tissue compression when applied to the skin.

A clinical study conducted in India reported that the test maintained high specificity and outperformed an expert clinician who conducted a conventional clinical breast examination. All malignant lesions were identified by the device, while the clinician failed to identify a non-palpable lesion.

UE Lifesciences won the 2016 Hitlab world cup at the Hitlab Innovators Summit in New York for their iBreastExam system. This prize is awarded to a healthcare startup deemed to have made an outstanding contribution in improving the delivery and accessibility of healthcare worldwide.

Matthew Campisi, CTO of UE LifeSciences made the following statement:

“We are truly grateful to have won the HITLAB World Cup and to be part of such a terrific program. As we continue to scale our iBreastExam product offering, collaboration with partners like HITLAB will help create awareness and establish key partnerships.”

Here’s a promo video from UE LifeSciences:

 

 

Product page: iBreastExam…

Link: UE Lifesciences…

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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

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Ansell introduces GAMMEX N95 Respirator and Surgical Mask

Ansell introduces GAMMEX N95 Respirator and Surgical Mask

Ansell, a global leader in protection solutions today announced the latest addition to its Active Infection Protection (AIP) portfolio, the GAMMEX N95 Respirator and Surgical Mask, extending the AIP range beyond surgical gloves. This new mask is the first to utilize a hybrid technology that incorporates the comfort of a standard surgical mask with the protection of a respirator. The mask is designed to more comfortably protect healthcare workers and patients from harmful airborne pathogens, therefore reducing the risk of Healthcare Associated Infection (HAI).

The GAMMEX N95 Respirator and Surgical Mask filters out 95% of airborne particles down to 0.1 micron in size, exceeding the worldwide standard for respirators of 0.3 microns set by the National Institute for Occupational Safety and Health (NIOSH), US FDA, and Health Canada. This allows the mask to remove many airborne particles contained in surgical smoke and filter out 99.9% of airborne viruses and bacterial microorganisms. Its high filtration capability, combined with TYPE II fluid resistance, makes the new GAMMEX N95 Respirator and Surgical Mask a critical component in personal protection for Infection Control, Isolation, ICU, ER, OR and many other areas subject to airborne pathogens and harmful particles.

The GAMMEX N95 Respirator and Surgical Mask is designed for unrivalled comfort and performance. Its patented Breathable Face Seal allows air to circulate through the top, bottom and sides of the respirator, ensuring maximum breathability. The unique design feels lighter and cooler so it can be worn comfortably for longer periods of time, promoting compliance and further enhancing infection prevention.

“This addition to the Ansell Active Infection Protection portfolio, coupled with our antimicrobial surgical gloves and a series of products currently in our pipeline, demonstrates our commitment to delivering clinically relevant solutions in infection prevention to help in the fight against healthcare associated infections,” said Anthony B. Lopez, President and General Business Manager, Ansell Medical Solutions.

“In line with our focus on innovation, the GAMMEX N95 Respirator and Surgical Mask provides a unique technological solution, specialized for the demands of the healthcare environment where exposure to airborne pathogens is high,” he continued.

The GAMMEX brand offers the most innovative and technologically advanced solutions worldwide, protecting against external aggression, allergic reactions and microbial contamination in the perioperative environment. The GAMMEX N95 Respirator and Surgical Mask is now available for sale in North America, with global rollout to follow in 2013.

Source : http://www.news-medical.net/news/20121203/Ansell-introduces-GAMMEX-N95-Respirator-and-Surgical-Mask.aspx

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Hemorr-Ice Gives War on Hemorrhoids a Much Needed Surge

Hemorr-Ice Gives War on Hemorrhoids a Much Needed Surge

Hemorr-Ice Gives War on Hemorrhoids a Much Needed Surge

Not a suppository, not an ointment, but a new clinically-tested method of treating hemorrhoids with cold therapy.

Hemorr-Ice has a special cooling liquid sealed inside so it acts like an ice pack on your hemorrhoid.

Shrinks blood vessels, reduces bleeding and promotes healing of inflamed tissues.

Simply apply the chilled inserter for two to five minutes.

Provides fast relief from pain, itching and bleeding.

Safe to use as often as desired.

Pictured here is the Hemorr-Ice, a minimally invasive device which claims to help with symptoms of hemorrhoids. Designed to be chilled next to the deli slices in the fridge, the unit can be shoved __ ____ ___ to cool down the burning feeling from within.

Going for 2/$16.99, you can get one for yourself and a friend at Carol Wright Gifts.

At Carol Wright Gifts we feature a large selection of great gift ideas, including Women’s Apparel, Discount Home Furnishings, and Bedroom Accessories. In our Women’s Apparel section you’ll find great deals on our new Terry Romper or our Kymaro Body Shaper.

Carol Wright Gifts is your one stop shop for Fitted Tablecloths, a Sobakawa Pillow, or even Stem Cell Therapy.

In addition to our large selection of Women’s Apparel we have the newest As Seen on TV products. Our As Seen on TV selection includes the new Yoshiblade and the Kymaro Curve Control Jeans. If you’re looking for the best deals on the web, visit our Clearance outlet, featuring items up to 80% off!

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Source : http://www.carolwrightgifts.com/

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Surgical Information Systems expands system-wide use of SIS solution

Surgical Information Systems expands system-wide use of SIS solution

Surgical Information Systems (“SIS”), a leader in perioperative information systems, announced that MedCentral Health System has expanded its system-wide use of the SIS solution to include anesthesia automation, perioperative analytics, patient tracking, and integrated tissue tracking as part of their single perioperative record. MedCentral Health System, the largest medical provider between Cleveland, Ohio and Columbus, Ohio, was also the first hospital system in the United States to attest to Meaningful Use.

The hospital recognized the need to expand its use of the SIS solution to keep up with increasing cost pressures as well as support the growing importance of quality initiatives. The expansion will include both of the facility’s acute care hospitals as well as their surgery center. Reducing costs in the OR is a critical component of hospitals’ strategies to manage changing reimbursement models such as Value-Based Purchasing (VBP). Beginning this month, the VBP model lowers reimbursement payments to hospitals by 1% and begins to link reimbursement to the quality of care rather than the quantity of procedures performed. Seven of the twelve clinical quality measures in a hospital’s VBP Total Performance Score are operating room Surgical Care Improvement Project (SCIP) measures.

“Hospitals are constantly challenged to reduce costs while providing safe and efficient care to our patients,” said Mike Mistretta, Vice President and CIO at MedCentral Health System. “Completely automating the perioperative suite with SIS supports our goals to deliver safe, efficient quality care while alleviating some of those cost pressures such as VBP and other changing payment models.”

An anesthesia information management system (AIMS) designed to streamline clinical workflows;

Role-based analytics to assist in better understanding and managing surgical operations, including anesthesia-specific information;

Patient tracking through all phases of care to improve communications and core metrics including on time case starts and room turnover times; and

Integrated tissue management to provide standardized processes that accurately and efficiently manage tissue inventory, reducing waste, lowering costs, and supporting The Joint Commission and other compliance efforts.

The SIS Complete Periop solution, including these key applications, integrates with the hospital’s Siemens Soarian® health information system, improving efficiency and communication across the care continuum.

“The SIS solution delivers a comprehensive perioperative patient record across our two hospitals and surgery center and integrates with our enterprise Soarian system,” Mistretta added. “Adding functionality for anesthesia documentation and analytics, as well as enterprise interoperability, will help ensure that clinicians can access electronic patient information across the full continuum of care for our patients.”

“As the first hospital to attest to Meaningful Use, MedCentral is a well-known innovator in healthcare information technology, dedicated to quality care,” said Ed Daihl, SIS Chief Executive Officer. Working closely with Siemens as their exclusive partner for perioperative IT, we’ve developed world-class interoperability with Siemens Soarian that will help MedCentral maintain its status as a health IT pioneer and deliver high levels of care quality and financial performance demanded by the industry today.”

Source : http://www.news-medical.net/news/20121117/Surgical-Information-Systems-expands-system-wide-use-of-SIS-solution.aspx

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Laser System Creates Near Perfect Lens Pocket for Cataract Surgery

Laser System Creates Near Perfect Lens Pocket for Cataract Surgery

Laser System Creates Near Perfect Lens Pocket for Cataract Surgery

Imagine trying to cut by hand a perfect circle roughly one-third the size of a penny. Then consider that instead of a sheet of paper, you’re working with a scalpel and a thin, elastic, transparent layer of tissue, which both offers resistance and tears easily. And, by the way, you’re doing it inside someone’s eye, and a slip could result in a serious impairment to vision.

This standard step in cataract surgery — the removal of a disc from the capsule surrounding the eye’s lens, a procedure known as capsulorhexis — is one of the few aspects of the operation that has yet to be enhanced by technology, but new developments in guided lasers could soon eliminate the need for such manual dexterity. A paper from Stanford University School of Medicine, published Nov. 17 in Science Translational Medicine, presents clinical findings about how one new system for femtosecond laser-assisted cataract surgery is not only safe but also cuts circles in lens capsules that are 12 times more precise than those achieved by the traditional method, as well as leaving edges that are twice as strong in the remaining capsule, which serves as a pocket in which the surgeon places the plastic replacement lens.

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» Let there be light

“The results were much better in a number of ways — increasing safety, improving precision and reproducibility, and standardizing the procedure,” said Daniel Palanker, PhD, associate professor of ophthalmology, who is the lead author of the paper. “Many medical residents are fearful of doing capsulorhexis, and it can be challenging to learn. This new approach could make this procedure less dependent on surgical skill and allow for greater consistency.” The senior author is William Culbertson, MD, professor of ophthalmology at the Bascom Palmer Eye Institute at the University of Miami.

While the technology to perform this new approach — called a capsulotomy instead of capsulorhexis — is being developed by a number of private companies, this paper focuses on a specific system being produced by OpticaMedica Corp. of Santa Clara, Calif., which funded the study. Palanker, Culbertson and five other co-authors have equity stakes in the company; the remaining seven co-authors are company employees.

Cataract surgery is the most commonly performed surgery in the nation, with more than 1.5 million of these procedures done annually. The operation is necessary when a cloud forms in the eye’s lens, causing blurred and double vision and sensitivity to light and glare, among other symptoms.

Courtesy of Daniel Palanker description of photo

Representative examples of lens capsule extraction by manual capsulorhexis (Row A) are not as close to being perfect circles and less uniform than those from laser capsulotomy (Row B).

The current procedure involves making an incision in the eye and then performing capsulorhexis: in that step, the paper explains, “The size, shape and position of the anterior capsular opening … is controlled by a freehand pulling and tearing the capsular tissue.” After that, the lens is broken up with an ultrasound probe and suctioned out. The surgery culminates with the placement — as snugly as possible — of an artificial intraocular lens in the empty pocket created in the capsule. Before closing the eye, the surgeon may make additional incisions in the cornea to prevent or lessen astigmatism.

With the new system, a laser can pass through the outer tissue — without the eye being opened — to cut the hole in the capsule and to slice up the cataract and lens, all of which occurs just before the patient enters the operating suite. The laser also creates a multi-planar incision through the cornea that stops just below the outermost surface, which means that the surgeon needs to cut less once the operation begins, as well as decreasing the risk of infection. Because of the laser work, once the operation is under way, the removal of the cut section of the capsule and the sliced-up lens can be done relatively easily, with much less need for the ultrasound energy.

Femtosecond lasers, which deliver pulses of energy per quadrillionths of a second, were already being widely and successfully used to reshape the cornea of the eye to correct nearsightedness, farsightedness and astigmatisms. For use in cataract surgery, however, the laser would need to cut tissue deep inside the eye. While the laser would need to reach a level of intensity strong enough to ionize tissue at a selected focal point, it would also have to have pulse energy and average power low enough to avoid collateral damage to the surrounding tissue, retina and other parts of the eye.

Palanker and his team found the proper balance through a series of experiments on enucleated porcine and human eyes. They then did further experiments to confirm that a laser at those settings would not cause retinal damage.

Still, a major hurdle remained. The laser needed to be guided as it made its incisions to ensure that it did not go astray, cutting nearby tissue, and that it would meet exacting specifications for the size of the disc-shaped hole in the lens capsule that it would be creating. The solution? Use optical coherence tomography — a noncontact, noninvasive in vivo imaging technique — to get a three-dimensional map of the eye. Using that image, he and his colleagues developed software that pinpoints the ideal pattern for the laser to follow. It is then superimposed on a three-dimensional picture of the patient’s eye, so that the surgeon can confirm it’s on track before starting the procedure, in addition to monitoring it as the cutting proceeds.

“Until this, we had no way to quantify the precision, no way to measure the size and shape of the capsular opening,” Palanker said.

A clinical trial in 50 patients revealed no significant adverse events, supporting the study’s goal of showing that the procedure is safe. What’s more, the laser-based system came much closer to adhering to the intended size of the capsular disc (typically coming within 25 micrometers with the laser vs. 305 micrometers in the manual procedure). And using a measurement that ranks a perfect circle as a 1.0, the researchers found that the laser-based technique scored about .95 as compared with about .77 for the manual approach to cutting the disc from the capsule.

What this means is that when the plastic intraocular lens is placed in the capsular bag, it’s going to be better centered and have a tighter fit, reducing the chances of a lens shift and improving the alignment of the lens with the pupil. This is increasingly important as more patients choose to have multifocal and accommodating lenses, which need to be aligned more precisely with the pupil to function well.

The laser-assisted surgery offered other benefits aside from the capsulotomy. The paper notes that because the laser has already spliced the lens, there’s less need to use the ultrasound probe. Its excessive use in hard cataracts can sometimes create too much heat and damage the corneal endothelium and other surrounding tissue. The laser also can create a multi-planar zigzag pattern for the incision in the cornea, allowing the incision to self-seal and decreasing the likelihood of infection and other complications.

While not an endpoint of the study, the researchers found that the new procedure did improve visual acuity more than the traditional approach; however, the difference was not statistically significant due to the small number of patients enrolled. Palanker said a properly designed clinical study is needed to quantify improvements in vision with various types of intraocular lenses; such research may take place in the United States if the U.S. Food and Drug Administration approves the new machine. Data from Palanker’s study is going to be submitted to the FDA for consideration.

“This will undoubtedly affect millions of people, as cataracts are so common,” said Palanker, though he expects that it will take time for the new procedure to be adopted. At present, the new procedure takes longer than the current standard, and it would cost more, with Medicare unlikely to cover it in the immediate future. “But there will be people who elect to have it done the new way if they can afford it. There are competitors coming out with related systems. This is what’s exciting. This technology is going to be picked up in the clinic.”

The other Stanford co- author is Mark Blumenkranz, MD, professor and chair of ophthalmology. Information about the Department of Ophthalmology, which also supported the work, is available at http://ophthalmology.stanford.edu/.

About one-third of people in the developed world will undergo cataract surgery in their lifetime. Although marked improvements in surgical technique have occurred since the development of the current approach to lens replacement in the late 1960s and early 1970s, some critical steps of the procedure can still only be executed with limited precision. Current practice requires manual formation of an opening in the anterior lens capsule, fragmentation and evacuation of the lens tissue with an ultrasound probe, and implantation of a plastic intraocular lens into the remaining capsular bag. The size, shape, and position of the anterior capsular opening (one of the most critical steps in the procedure) are controlled by freehand pulling and tearing of the capsular tissue. Here, we report a technique that improves the precision and reproducibility of cataract surgery by performing anterior capsulotomy, lens segmentation, and corneal incisions with a femtosecond laser. The placement of the cuts was determined by imaging the anterior segment of the eye with integrated optical coherence tomography. Femtosecond laser produced continuous anterior capsular incisions, which were twice as strong and more than five times as precise in size and shape than manual capsulorhexis. Lens segmentation and softening simplified its emulsification and removal, decreasing the perceived cataract hardness by two grades. Three-dimensional cutting of the cornea guided by diagnostic imaging creates multiplanar self-sealing incisions and allows exact placement of the limbal relaxing incisions, potentially increasing the safety and performance of cataract surgery.

Though cataract surgery requires millimeter precision, it is still very much a manual procedure requiring steady hands on the part of the surgeon. A new system, developed at Stanford and being commercialized by OpticaMedica Corp. of Santa Clara, CA, uses a combination of a femto-second laser and integrated optical coherence tomography to precisely perform lens capsule extraction. Though current methodology is already relatively safe, the new system may lead to effectively error-free procedures and higher pupil alignment precision required for multifocal and accommodating lenses.

With the new system, a laser can pass through the outer tissue — without the eye being opened — to cut the hole in the capsule and to slice up the cataract and lens, all of which occurs just before the patient enters the operating suite. The laser also creates a multi-planar incision through the cornea that stops just below the outermost surface, which means that the surgeon needs to cut less once the operation begins, as well as decreasing the risk of infection. Because of the laser work, once the operation is under way, the removal of the cut section of the capsule and the sliced-up lens can be done relatively easily, with much less need for the ultrasound energy.

A clinical trial in 50 patients revealed no significant adverse events, supporting the study’s goal of showing that the procedure is safe. What’s more, the laser-based system came much closer to adhering to the intended size of the capsular disc (typically coming within 25 micrometers with the laser vs. 305 micrometers in the manual procedure). And using a measurement that ranks a perfect circle as a 1.0, the researchers found that the laser-based technique scored about .95 as compared with about .77 for the manual approach to cutting the disc from the capsule.

The laser-assisted surgery offered other benefits aside from the capsulotomy. The paper notes that because the laser has already spliced the lens, there’s less need to use the ultrasound probe. Its excessive use in hard cataracts can sometimes create too much heat and damage the corneal endothelium and other surrounding tissue. The laser also can create a multi-planar zigzag pattern for the incision in the cornea, allowing the incision to self-seal and decreasing the likelihood of infection and other complications.

Source : http://stm.sciencemag.org/content/2/58/58ra85.abstract?sid=ec6471aa-42de-4b1c-ac1f-c7f3ea0991ed

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Mindray initiates voluntary recall for A3/A5 Anesthesia Delivery System

Mindray initiates voluntary recall for A3/A5 Anesthesia Delivery System

Mindray Medical International Limited (NYSE: MR), a leading developer, manufacturer and marketer of medical devices worldwide, has initiated a voluntary recall affecting the A3/A5 Anesthesia Delivery System. Mindray has initiated this recall due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket.

Should a system leak occur during use, fresh gas flow may be increased to compensate for any pressure loss resulting from the leak while the absorbent canister is unlocked and locked again to reseat the gasket. If the CO2 absorbent canister gasket is improperly seated, however, a potential leak will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case, at which time the absorbent canister can be unlocked and locked again to reseat the gasket.

The canister gasket subject to this recall may be identified by presence of a small “step” in the gasket surface. A3/A5 units with this gasket may continue to be used. The proper seating of the canister gasket should be confirmed prior to use and after CO2 absorbent is changed.

Customers who have a system(s) subject to this recall were notified by on August 8, 2012 by letter via US Postal Mail, return receipt required. To date, approximately 70% of units affected by this action have been corrected. The issue is corrected through a replacement of the canister gasket by a Mindray Service or authorized representative.

Units with the affected canister gaskets were shipped between May 31, 2011 and July 15, 2012 in the United States, Latin America and Australia.

There have been no reports of injuries associated with this issue. Mindray became aware of the issue when a system leak was reported by a customer. The cause of the leak was determined to be the result of an improperly seated canister gasket.

Mindray has advised the US Food and Drug Administration of this voluntary recall.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

Online: http://www.fda.gov/medwatch/report.htm

Regular mail: use postage-paid, pre-addressed Form FDA3500 available at http://www.fda.gov/MedWatch/getforms.htm

Fax: 1-800-FDA-0178

SOURCE Mindray Medical International Limited

Source : http://www.news-medical.net/news/20121114/Mindray-initiates-voluntary-recall-for-A3A5-Anesthesia-Delivery-System.aspx

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Leica Microsystems and TrueVision® 3D Surgical introduce digital 3D-integrated ophthalmic microscope

Leica Microsystems and TrueVision® 3D Surgical introduce digital 3D-integrated ophthalmic microscope

Leica Microsystems and TrueVision® 3D Surgical introduce digital 3D-integrated ophthalmic microscope

Leica Microsystems and TrueVision® 3D Surgical announced today that key components of the TrueVision® 3D intelligent digital visualization and guidance platform have been integrated with select future models of Leica Microsystems’ ophthalmic surgical microscopes and will be marketed under the Leica brand.

LeicaBy combining world-class Leica Microsystems optics and illumination with state-of-the-art TrueVision digital stereoscopic imaging, the two companies have partnered to debut a new class of surgical stereo microscope. Leica Microsystems and TrueVision will present the integrated TrueVision 3D/Leica microscope system at the 116th Annual Meeting of the American Academy of Ophthalmology at McCormick Place in Chicago, November 10-13, 2012, Booth 1576 and Booth 2739. It is the launch of a collaboration, which is expected to establish integrated 3D visualization and guidance as the standard of care in microsurgery.

The 3D digital integrated microscope can also run TrueVision’s Refractive Cataract Toolset® application. The toolset generates precise guidance templates in real-time using pre-operative data and advanced algorithms. Surgeons view the 3D live image on the microscope’s 3D HD flat panel display with computer generated overlays for dynamic guidance with eye tracking during the surgery.

“The TrueVision 3D visualization and computer-guided software platform integration with Leica surgical microscopes is a ground breaking tool for ophthalmologists,” says James Katz, MD, a board-certified ophthalmologist and TrueVision 3D/Leica user from the Midwest Center for Sight near Chicago. “This unprecedented pairing allows the surgeon to apply pre-operative diagnostic data at the point of surgery for limbal relaxing incision placement and toric IOL alignment in the live field of view on the 3D screen.”

“TrueVision is going beyond their surgical education roots, and is now making visualization and guidance very helpful as a tool to perform better surgery; particularly in complex surgeries. For example, in gonioscopic approaches, we are able to see a larger viewing area in terms of access to the canal or to the angle due to the stereoscopic immersive view of the surgical field on the 3D high-definition displays in the OR,” states Ike K. Ahmed, MD, FRCSC, assistant professor at the University of Toronto.

The TrueVision digital 3D system is completely integrated with the Leica M844 and M822 ophthalmic surgical microscopes when equipped with the Leica F40 stand. The system features a patented 10-megapixel HD 3D camera in the optics carrier, 64-bit image processing unit contained within the chassis, and dual passive stereo LED-based LCD displays ranging in size from 23 to 32 inches with articulating arms mounted on the microscope base. The 3D-enabled surgical microscopes are capable of displaying the surgical field of view with 3D guidance and digital overlays on secondary 2D or 3D displays in the operating room.

Leica Microsystems is a world leader in microscopes and scientific instruments. Founded as a family business in the nineteenth century, the company’s history was marked by unparalleled innovation on its way to becoming a global enterprise. Its historically close cooperation with the scientific community is the key to Leica Microsystems’ tradition of innovation, which draws on users’ ideas and creates solutions tailored to their requirements. At the global level, Leica Microsystems is organized in three divisions, all of which are among the leaders in their respective fields: the Life Science Division, Industry Division and Medical Division. The company is represented in over 100 countries with 6 manufacturing facilities in 5 countries, sales and service organizations in 20 countries, and an international network of dealers. The company is headquartered in Wetzlar, Germany. Visit www.leica-microsystems.com for more information.

TrueVision® 3D Surgical is the world leader in digital 3D visualization and guidance for microsurgery. Santa Barbara, California-based TrueVision® has developed and patented an intelligent, real-time, 3D surgical visualization and computer-aided guidance platform. The system enables surgeons to record surgery in 3D and to stream live video of the surgical field, making it an unparalleled teaching tool. The company is focused on developing a suite of 3D guidance applications for microsurgery to improve surgical efficiencies and patient outcomes. The system is in use at hundreds of hospitals and institutions around the world.

Source : http://www.news-medical.net/news/20121108/Leica-Microsystems-and-TrueVisionc2ae-3D-Surgical-introduce-digital-3D-integrated-ophthalmic-microscope.aspx

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