Posts Tagged ‘FDA’

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CAREFUSION RECEIVES 510(k) CLEARANCE FOR VERTEBRAL AUGMENTATION SYSTEM

CAREFUSION RECEIVES 510(k) CLEARANCE FOR VERTEBRAL AUGMENTATION SYSTEM

AVAflex® Vertebral Balloon System Enables Targeted Balloon Placement

Jan 30, 2014


SAN DIEGO, Jan. 30, 2014
 – CareFusion (NYSE:CFN), a leading global medical technology company, today announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new AVAflex® Vertebral Balloon System.

The new system is the latest innovation in CareFusion’s AVAmax®Advanced Vertebral Augmentation portfolio. The focus of these products is to provide a minimally invasive solution to treat vertebral compression fractures, while also promoting safety for the patient, physician and staff. The AVAflex Vertebral Balloon System combines the unique features of the AVAflex Curved Vertebral Augmentation Needle and the AVAmax Vertebral Balloon to enable targeted balloon placement across the midline of the vertebral body, followed by targeted cement placement for optimal fill through a single pedicle.

The AVAflex Vertebral Balloon System is in limited commercial release in multiple hospitals across the U.S.

“The ability to steer a balloon through a unipedicular approach cannot be overstated in its simplicity and efficiency,” said Dr. Michael Verdolin of Verdolin Pain Specialists in Chula Vista, Calif. after using the product. “The procedure was faster, with less patient discomfort.”

Dr. Allan Brook, an interventional radiologist with Montefiore Medical Center in Bronx, N.Y. and the first physician to use the new device on the East Coast, said “The unipedicular approach offers a less risky approach to the midline of a vertebral body. Having another tool that places the cavity in the desired location can improve the effectiveness of vertebral augmentation in less time and with less radiation.”

Another physician using the device in limited commercial release, Dr. Langham Gleason, a neurosurgeon with the South Texas Brain and Spine Center in Corpus Christi, Texas, said “The AVAflex Vertebral Balloon System works extremely well to allow bilateral fracture reduction using a unilateral approach. I suspect that placement of bilateral vertebral cannulas will largely fade away in the future.”

CareFusion expects a full commercial launch of the AVAflex Vertebral Balloon System in Spring 2014
.

Source : http://media.carefusion.com/index.php?s=32344&item=136851

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Digirad X-ACT Solid State SPECT Approved in Europe

Digirad X-ACT Solid State SPECT Approved in Europe

Digirad X-ACT Solid State SPECT Approved in Europe

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Adds to International Distribution Network

POWAY, CA — (MARKET WIRE) — 01/25/12 — Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union. The Cardius X-ACT imaging system was designed to increase diagnostic accuracy and make earlier detection of disease possible.

Digirad also announced that it had begun to strategically build out a targeted international selling network by signing a distribution agreement with Epsilon Elektronik in Turkey, a part of the Istanbul-based Bozlu Group. Last year, Digirad signed a similar agreement with UK-based Southern Scientific, which has already placed an ergo™ portable solid-state camera at the Manchester Royal Infirmary where it is being used in a number of general and surgical imaging settings.

“One of the legs of our transition to growth in the product category is to build a targeted network of top distributors in key international markets that have a growing demand for flexible, high-quality imaging products such as the X-ACT. Our experience and the data indicate that price point, flexibility and potential for better clinical outcomes at lower overall costs are key elements to healthcare buying decisions, and our growing line of camera products uniquely fits those requirements,” said Digirad CEO Todd P. Clyde. “It is our intention, as one of several new initiatives in 2012, to more aggressively build a distribution network to tap the developing markets for dedicated cardiac and portable nuclear imaging in a more meaningful way. To that end, gaining of CE Mark and additional distribution agreements are key initial elements of that process.”

The Cardius X-ACT imaging system features a low-dose volume-computed tomography attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues.

“We believe our Cardius X-ACT imaging system, our ergo flexible imaging camera and future camera models will be well-received internationally because of their accuracy, diagnostic benefits and economic models that fit well with healthcare spending. They all provide new clinical information that increases the benefit of nuclear cardiology procedures. That increase in diagnostic confidence can improve outcomes and raise the standard in the industry internationally for SPECT system performance at a price point that is accessible in many countries,” added Clyde.

Digirad has previously received clearance from the FDA to market the Cardius X-ACT imaging system in the U.S. and has garnered both CE Mark and FDA clearance to market its ergo portable solid-state camera.

About Digirad Corporation

Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit www.digirad.com. Digirad® and Cardius® are registered trademarks of Digirad Corporation.

Forward-Looking Statements

This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. These include statements regarding our ability to deliver value to customers and our expanded product and service offerings. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made, including the risks associated with changes in business conditions, technology, customers’ business conditions, reimbursement, radiopharmaceutical shortages, economic outlook, operational policy or structure, acceptance and use of Digirad’s camera systems and services, reliability, recalls, and other risks detailed in Digirad’s filings with the U.S. Securities and Exchange Commission, including Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other reports. Readers are cautioned to not place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Digirad undertakes no obligation to revise or update the forward-looking statements contained herein.

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability.

The company already has approval from the FDA to market the Cardius X-ACT in the U.S.

Source : http://drad.client.shareholder.com/releasedetail.cfm?ReleaseID=642105

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Swift-Lock to Make Lead Anchoring Fast and Easy

Swift-Lock to Make Lead Anchoring Fast and Easy

Swift-Lock to Make Lead Anchoring Fast and Easy

Celebrating 30 Years of Innovation in Neuromodulation, St. Jude Medical Unveils Latest Product at American Academy of Pain Medicine Annual Meeting

Company receives FDA clearance for Swift-Lock anchor, a new product for securing neurostimulation leads used in chronic pain therapy

ST. PAUL, Minn., Feb 03, 2010 (BUSINESS WIRE) — St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) clearance of the Swift-Lock(TM) anchor, a new product designed to help physicians efficiently secure neurostimulation leads utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. Introduced at the American Academy of Pain Medicine (AAPM) annual meeting, the Swift-Lock anchor builds on a 30-year history of developing industry-leading neurostimulation products.

Designed to reduce anchoring time and enhance procedural efficiency, the Swift-Lock anchor eliminates the need for sutures or medical adhesive typically required to secure the anchor to the lead. Featuring an easy-to-use mechanical lock, physicians secure the anchor with a simple 90-degree twist. This design minimizes the complexity and variability associated with anchoring leads.

“For more than 30 years we have focused on the development of the most advanced line of clinically relevant neurostimulation products to meet the needs of physicians and patients,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “The Swift-Lock anchor is yet another example of our commitment to provide best-in-class solutions to aid in the management of chronic pain.”

The Swift-Lock anchor features include:

Intuitive locking mechanism that provides tactile and visual confirmation that the lead is locked

Strong fixation to the lead to help mitigate the risk of migration

Highly radiopaque material to provide easy fluoroscopic visualization

Simple twist lock mechanism allows for easy repositioning of the lead if needed

Three decades of leading edge neurostimulation technology

For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today more than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.

Some of the innovative products that St. Jude Medical was first to bring to market include:

World’s smallest neurostimulator for chronic pain – the Eon Mini(TM) spinal cord stimulator

First-of-its-kind five-column paddle lead — the Penta(TM) lead

Next-generation programming platform used to optimize neurostimulation therapy — MultiSteering(TM) Technology software for Rapid Programmer(TM)

First spinal cord stimulator with constant current circuitry – the Genesis(TM) neurostimulator

World’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson’s disease — the Brio(TM) neurostimulator (CE Mark approval)

Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Clinical studies are currently underway for Parkinson’s disease, essential tremor, migraine headaches, major depressive disorder, and others.

Spinal cord stimulators are implanted neurostimulation devices that send mild electrical pulses from an implanted device to leads that are placed in the epidural space. These low intensity pulses interrupt the pain signals’ pathways to the brain by stimulating selective nerve fibers along the spinal cord. More information can be obtained about neurostimulation therapy at www.PowerOverYourPain.com.

Chronic pain affects millions of patients worldwide. In the U.S., more than 76.5 million people are categorized as suffering from chronic pain by the American Pain Foundation. Estimates by the National Institutes of Health place the costs for lost work time and healthcare expenses at approximately $100 billion every year.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

At the ongoing American Academy of Pain Medicine annual meeting in San Antonio, St. Jude Medical unveiled the new Swift-Lock anchor for neurostimulation leads. The device was just approved by the FDA as an easier option of attaching anchors to leads of implantable neurostimulators.

From the announcement:

Designed to reduce anchoring time and enhance procedural efficiency, the Swift-Lock anchor eliminates the need for sutures or medical adhesive typically required to secure the anchor to the lead. Featuring an easy-to-use mechanical lock, physicians secure the anchor with a simple 90-degree twist. This design minimizes the complexity and variability associated with anchoring leads.

The Swift-Lock anchor features include:

Intuitive locking mechanism that provides tactile and visual confirmation that the lead is locked

Strong fixation to the lead to help mitigate the risk of migration

Highly radiopaque material to provide easy fluoroscopic visualization

Simple twist lock mechanism allows for easy repositioning of the lead if needed

source : http://phx.corporate-ir.net/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1382624&highlight=

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LDR Mobi-C Cervical Disk May Soon be First Dual Level Implant Available in U.S.

LDR Mobi-C Cervical Disk May Soon be First Dual Level Implant Available in U.S.

LDR Mobi-C Cervical Disk May Soon be First Dual Level Implant Available in U.S.

LDR Receives Approvable Letter from U.S. Food and Drug Administration for Two-­Level Mobi-C® Cervical Disc

Mobi-C is the first cervical disc to receive an approvable letter for two-level use in the United States following a 600 patient concurrent IDE Clinical Trial for one and two-level cervical disc replacement

LDR Receives Approvable Letter from U.S. Food and Drug Administration for Two-­Level Mobi-C® Cervical Disc

AUSTIN, TX (November 6, 2012) – LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its Mobi-C® Cervical Disc (Mobi-C). Mobi-C is a metal and polyethylene mobile bearing prosthesis specifically designed as a low-profile cervical intervertebral disc replacement for both one and two level applications.

“We are pleased that the FDA, after an intensive review of our submission for Mobi-C, has determined it to be approvable based on the strength of the data provided in the premarket approval application (PMA). We are confident that we can efficiently complete the remaining requirements inherent in the full approval process and we anticipate commercial U.S. availability of Mobi-C in 2013,” said Christophe Lavigne, President and CEO of LDR. “Given the high incidence of two-level cervical disease, we are proud that Mobi-C may become the first cervical disc available to treat patients on-label that suffer from two-level pathology. I would like to thank and attribute this success to everyone involved in this study, especially the clinicians, study coordinators, the FDA, LDR employees, our partners and suppliers, and most importantly the patients who consented to participate in the first prospective study performed comparing Mobi-C to ACDF.”

FDA has determined that Mobi-C is approvable for two-level indications, subject to the satisfaction of all applicable requirements of the Quality System Regulations (21 CFR Part 820), as well as finalization of the labeling and post-approval study. FDA will issue an approval order, allowing commercial sale and distribution, after said requirements have been reviewed and determined to be acceptable.

“The Mobi-C two-level study data, as presented at the North American Spine Society (NASS) 2012 Annual Meeting, demonstrate the potential to treat two-level cervical disease using the Mobi-C Cervical Disc as an alternative to ACDF,” said Dr. Reginald Davis, Chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center. “The anticipated full approval of Mobi-C will give surgeons a valuable treatment option for patients with two-level disease, where there is no approved motion preserving option.”

About LDR

LDR develops unique implantable spine devices and instrumentation designed to support the clinical goals of surgery while making procedures easier to perform. LDR was founded in 2000 by partners Christophe Lavigne, Hervé Dinville and Patrick Richard in Troyes, France. Headquartered in Austin, TX, LDR has experienced growth through product portfolio expansion and an increasingly global presence. More information is located at www.ldrmedical.com.

Caution: The Mobi-C® device is for investigational use only and is not available for use in the United States.

The Avenue L Lateral Lumber Cage System from LDR (Austin, TX) received 510(k) clearance, opening the way for the first lateral lumbar cage with integrated in-line plating to be sold in the U.S. The device has been on the market in Europe since 2010.

Designed to stabilize lumbar spinal segments to promote fusion, the device offers the company’s proprietary in-line, self-guided VerteBRIDGE plating technology, which has been used in more than 25,000 cage implantation procedures since it debuted in 2008.

The Avenue L Lateral Lumbar Cage System is intended for intervertebral body fusion of the lumbar spine, from the L2 to S1 vertebrae. The intervertebral cages in the device are made from PEEK OPTIMA Lii (ASTM F2026) and titanium alloy markers to enhance X-ray imaging. The system must be used with posterior supplemental fixation such as pedicle screws.

From the press release:

The Avenue L cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a minimally invasive direct lateral approach, so that the implantation may be achieved with less exposure than may be required of other lateral systems with integrated screws that must be inserted at divergent angles. The system features thoughtfully designed instrumentation including an inserter that protects anatomical structures while implanting the cage and plating. Avenue L has been implanted via a pre-psoatic approach without neurological monitoring in Europe, and is also compatible with the direct lateral trans-psoatic approach common in the United States.

The controlled mobility of the mobile insert is the foundation of the Mobi-C® disc prosthesis. This second generation artificial disc was designed by a team of surgeons specializing in spinal arthroplasty.

Mobi-C has a unique, reliable and patented implantation system: the « Plug & Fit » technology.

It provides you with an ease of use and modularity unequaled in the domain of cervical arthroplasty while preserving the core philosophy of Mobi-C: the resoration of physiological biomecanics with a controlled mobility insert.

LDR Medical (Austin, Texas) received an Approval Letter from the FDA paving way for the company’s Mobi-C metal and polyethylene cervical disk mobile bearing prosthesis to come U.S. to market. This would be the first cervical implant available in America to treat two adjacent levels of damaged disks.

The Mobi-C is applicable for both one and two level procedures, and the company touts its low-profile, easy control for the surgeon, and reliable anchorage.

FDA has determined that Mobi-C is approvable for two-level indications, subject to the satisfaction of all applicable requirements of the Quality System Regulations (21 CFR Part 820), as well as finalization of the labeling and post-approval study. FDA will issue an approval order, allowing commercial sale and distribution, after said requirements have been reviewed and determined to be acceptable.

“The Mobi-C two-level study data, as presented at the North American Spine Society (NASS) 2012 Annual Meeting, demonstrate the potential to treat two-level cervical disease using the Mobi-C Cervical Disc as an alternative to ACDF,” said Dr. Reginald Davis, Chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center. “The anticipated full approval of Mobi-C will give surgeons a valuable treatment option for patients with two-level disease, where there is no approved motion preserving option.”

source : http://www.ldrmedical.com/News/ArtMID/944/ArticleID/196/LDR-Receives-Approvable-Letter-from-US-Food-and-Drug-Administration-for-Two-%C2%ADLevel-Mobi-C%C2%AE-Cervical-Disc

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Digirad X-ACT Solid State SPECT Approved in Europe

Digirad X-ACT Solid State SPECT Approved in Europe

Digirad X-ACT Solid State SPECT Approved in Europe

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Adds to International Distribution Network

POWAY, CA — (MARKET WIRE) — 01/25/12 — Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union. The Cardius X-ACT imaging system was designed to increase diagnostic accuracy and make earlier detection of disease possible.

Digirad also announced that it had begun to strategically build out a targeted international selling network by signing a distribution agreement with Epsilon Elektronik in Turkey, a part of the Istanbul-based Bozlu Group. Last year, Digirad signed a similar agreement with UK-based Southern Scientific, which has already placed an ergo™ portable solid-state camera at the Manchester Royal Infirmary where it is being used in a number of general and surgical imaging settings.

“One of the legs of our transition to growth in the product category is to build a targeted network of top distributors in key international markets that have a growing demand for flexible, high-quality imaging products such as the X-ACT. Our experience and the data indicate that price point, flexibility and potential for better clinical outcomes at lower overall costs are key elements to healthcare buying decisions, and our growing line of camera products uniquely fits those requirements,” said Digirad CEO Todd P. Clyde. “It is our intention, as one of several new initiatives in 2012, to more aggressively build a distribution network to tap the developing markets for dedicated cardiac and portable nuclear imaging in a more meaningful way. To that end, gaining of CE Mark and additional distribution agreements are key initial elements of that process.”

The Cardius X-ACT imaging system features a low-dose volume-computed tomography attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues.

“We believe our Cardius X-ACT imaging system, our ergo flexible imaging camera and future camera models will be well-received internationally because of their accuracy, diagnostic benefits and economic models that fit well with healthcare spending. They all provide new clinical information that increases the benefit of nuclear cardiology procedures. That increase in diagnostic confidence can improve outcomes and raise the standard in the industry internationally for SPECT system performance at a price point that is accessible in many countries,” added Clyde.

Digirad has previously received clearance from the FDA to market the Cardius X-ACT imaging system in the U.S. and has garnered both CE Mark and FDA clearance to market its ergo portable solid-state camera.

About Digirad Corporation

Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit www.digirad.com. Digirad® and Cardius® are registered trademarks of Digirad Corporation.

Forward-Looking Statements

This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. These include statements regarding our ability to deliver value to customers and our expanded product and service offerings. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made, including the risks associated with changes in business conditions, technology, customers’ business conditions, reimbursement, radiopharmaceutical shortages, economic outlook, operational policy or structure, acceptance and use of Digirad’s camera systems and services, reliability, recalls, and other risks detailed in Digirad’s filings with the U.S. Securities and Exchange Commission, including Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other reports. Readers are cautioned to not place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Digirad undertakes no obligation to revise or update the forward-looking statements contained herein.

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability.

The company already has approval from the FDA to market the Cardius X-ACT in the U.S.

Source : http://drad.client.shareholder.com/releasedetail.cfm?ReleaseID=642105

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Osseoflex SB Steerable Inflatable Bone Tamp Coming to U.S.

Osseoflex SB Steerable Inflatable Bone Tamp Coming to U.S.

Osseoflex SB Steerable Inflatable Bone Tamp Coming to U.S.

SANTA ROSA, CA – October 24, 2012 – Osseon® Therapeutics, Inc. announced today the commercial release in the U.S. of its newest product, the Osseoflex® SB steerable inflatable bone tamp. After successful launch and distribution in Europe, the Osseoflex SB has received FDA clearance for sale in the U.S.

Osseon will be displaying its portfolio of steerable vertebral augmentation products at the NASS (North American Spine Society) tradeshow in Dallas, TX, Booth #2914, from October 24th-26th.

About Osseon:

Osseon Therapeutics, Inc., headquartered in Santa Rosa, CA, is dedicated to developing and commercializing state of the art medical devices for minimally invasive treatments for degenerative bone and joint disease, including the treatment of vertebral compression fractures. The company’s patented, steerable delivery system offers more treatment options than other commercial solutions as well as offering significant advantages in procedural efficiency and cost. By improving the treatment of compression fractures within the lower portion of the thoracic and the entire lumbar vertebral spine, Osseon offers new, forward thinking solutions to patients suffering from these maladies, as well as to the physicians and medical facilities that treat them. Osseon’s products are distributed globally.

For more information, visit our website at osseon.com.

Osseon® is a registered trademark of Osseon Therapeutics, Inc. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

The Osseoflex® SB is an inflatable bone tamp used for cavity creation that provides access to the entire vertebral body, for the treatment of vertebral compression fractures.

Utilizing either a bipedicular or unipedicular approach, (based on the channel created by the Osseoflex SN+) the Osseoflex SB compacts cancellous bone and allows bone cement to be delivered with precision directly to the pathology. If used unipedicular, the single point access reduces procedure time and decreases risk to the patient.

Osseon Therapeutics (Santa Rosa, California) has announced FDA clearance and U.S. market rollout of its Osseoflex SB steerable inflatable bone tamp. It has already been cleared and is in use by orthopedic surgeons in Europe.

The Osseoflex SB is used to compact bone using an inflatable balloon and can create a central cavity across the sagittal midline during treatment for vertebral compression fractures.

Features from the product page:

Inflation / Deflation

Ergonomic design

Easy to read luminescent gauge

Pressure and volume readings show cortical bone movement

Source : http://www.osseon.com/press-releases/osseon-receives-fda-clearance-for-latest-steerable-vcf-product/

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FDA Clears Smith & Nephew’s Single-Use Negative Pressure Wound Therapy System

FDA Clears Smith & Nephew’s Single-Use Negative Pressure Wound Therapy System

FDA Clears Smith & Nephew’s Single-Use Negative Pressure Wound Therapy System

High moisture vapor transpiration rate (MVTR) top film allows one-way transpiration of exudate vapor

Proprietary absorbent layer moves exudate away from the wound and initiates evaporation

Airlock layer maintains open airflow and allows even distribution of negative pressure across the dressing

Silicone contact allows fluid to pass and minimizes pain of removal

January 6, 2012 /PRNewswire/ — Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces the FDA clearance of the pocket-sized PICO? system, a single use Negative Pressure Wound Therapy (NPWT) system. PICO is cleared for use both in a hospital and homecare setting and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures. This FDA clearance follows the recent successful launch of PICO in Europe, Canada, and Australia.

“PICO is novel and beneficial in several regards,” said Dr. Raymond Dunn, Chairman of Plastic Surgery, University of Massachusetts. “The seven day duration should allow us to more rapidly transition care for patients with post-operative wounds and skin grafts to the outpatient setting. With the simple pump, on-off design and absence of any canister or reservoir for fluid, patients can manage their NPWT at home much more easily, without additional nursing visits. This saves the healthcare system money and improves patients’ quality of life.”

Smith & Nephew has been a leader in the wound care market for more than a century. The company has employed years of customer feedback and market research in the PICO system’s design to ensure a patient friendly experience that addresses the needs and preferences of clinicians and payers as well.

Clinicians can be confident that the PICO system is providing NPWT safely and effectively in a wide range of wounds and care settings. The PICO system is indicated for chronic, acute and traumatic wounds, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts, and closed surgical incisions. The PICO system is as easy to apply as a conventional wound dressing, reducing the need for the staff time, intensive training and administrative paperwork associated with traditional NPWT. The simple application technique can be viewed online via an MS Tag included on the packaging.

For the patient, the PICO system’s one-button pump is easy-to-use and its small size and silent operation provide a discreet, unobtrusive way to carry on daily life with NPWT. The disposable device works with a revolutionary dressing technology that manages fluids, eliminating the need for bulky canisters. The system can be worn on a wound up to a week, depending on the level of exudates. Its gentle silicone wound contact layer helps minimize pain at a dressing change.

For the Payer, the PICO system is more affordable than traditional NPWT, and can significantly reduce therapy costs associated with traditional NPWT. The PICO system is available off-the-shelf and therefore may reduce the occurrence of delayed hospital discharges.

“We are the first company to deliver effective, single use, disposable NPWT using the combination of a small, portable pump and advanced dressing technology,” said Thomas Dugan, President, Smith & Nephew Advanced Wound Management, North America. “The PICO system demonstrates our commitment to innovation and reinforces our pledge to help reduce the human and economic cost of wounds.”

Clinicians and patients can also refer to the 24/7 negative pressure wound therapy hotline, 866-998-NPWT (6798), for more information about the NPWT portfolio of products from Smith & Nephew.

For more information about the PICO system, please visit our mobile compatible website at www.possiblewithpico.com or follow the @woundcare Twitter handle for the latest news from the Advanced Wound Management division of Smith & Nephew. Register at www.twitter.com today.

Inquiries

Thomas Dugan

(727) 399-3766

President

Advanced Wound Management, North America

Smith & Nephew

Media

Steve DiMattia

(646) 201-5445

EVC Group, Inc.

Analyst/Investor

Phil Cowdy

+44 (0) 20 7401 7646

Smith & Nephew

About Smith & Nephew

Smith & Nephew is a global medical technology business with global leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine, Trauma and Clinical Therapies. The Company has distribution channels, purchasing agents and buying entities in over 90 countries worldwide. Annual sales in 2010 were nearly $4.0 billion.

Smith & Nephew is dedicated to helping improve people’s lives. The Company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust.

Forward-Looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payors and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions and our success in integrating acquired businesses; and numerous other matters that affect us or our markets, including those of a political, economic, business or competitive nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors.

Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

? Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

The human body’s first layer of defense – skin – can be compromised in many ways: abrasions, burns, and cuts, to name a few. Deep wounds require deep cleansing in order to prevent the development and spread of infections. Over the last two decades the wound treatment community has seen an increasing use of negative pressure (that is, vacuum) pumps in order to tightly seal wound dressings and remove edema, or fluid buildup.

The London-based medical device company Smith & Nephew announced today that the FDA cleared its newest device, PICO, which is a single-use negative pressure wound therapy (NPWT) system. According to the press release, PICO offers several advantages to heatlhcare providers, patients, and payers alike:

PICO illustration FDA Clears Smith & Nephews Single Use Negative Pressure Wound Therapy System

Clinicians can be confident that the PICO system is providing NPWT safely and effectively in a wide range of wounds and care settings. The PICO system is indicated for chronic, acute and traumatic wounds, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts, and closed surgical incisions. The PICO system is as easy to apply as a conventional wound dressing, reducing the need for the staff time, intensive training and administrative paperwork associated with traditional NPWT.

For the patient, the PICO system’s one-button pump is easy-to-use and its small size and silent operation provide a discreet, unobtrusive way to carry on daily life with NPWT. The disposable device works with a revolutionary dressing technology that manages fluids, eliminating the need for bulky canisters. The system can be worn on a wound up to a week, depending on the level of exudates. Its gentle silicone wound contact layer helps minimize pain at a dressing change.

For the Payer, the PICO system is more affordable than traditional NPWT, and can significantly reduce therapy costs associated with traditional NPWT. The PICO system is available off-the-shelf and therefore may reduce the occurrence of delayed hospital discharges.

Source : http://www.multivu.com/mnr/51011-smith-nephew-pico-system-fda-approval-npwt

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Merit Laureate Hydrophilic Guide Wire Back on Sale

Merit Laureate Hydrophilic Guide Wire Back on Sale

Merit Laureate Hydrophilic Guide Wire Back on Sale

The Merit Laureate hydrophilic guide wire facilitates the placement of devices during diagnostic and interventional procedures. Its exceptional torque control, turn-for-turn responsiveness, and enhanced lesion crossability demonstrates high performance in navigating tortuous vessels. The hydrophilic coating demonstrates enduring lubricity and consistent surface coating adhesion. The Laureate was designed to reduce wire whipping, minimize friction, and to promote rapid catheter exchanges.

Merit Medical has received FDA clearance to bring to market its Merit Laureate hydrophilic guide wire, having addressed some manufacturing issues that the FDA had concerns about.

The product promises improved usability for the physician, allowing for one-to-one control of the distal tip with reduced whipping common to other guidewires.

Some features from the product page:

Its exceptional torque control, turn-for-turn responsiveness, and enhanced lesion crossability demonstrates high performance in navigating tortuous vessels. The hydrophilic coating demonstrates enduring lubricity and consistent surface coating adhesion. The Laureate was designed to reduce wire whipping, minimize friction, and to promote rapid catheter exchanges.

SOUTH JORDAN, Utah, Sept. 24, 2012 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received 510(k) clearance from the Food and Drug Administration to market the Merit Laureate® hydrophilic guide wire.

In February 2012, Merit Medical received a warning letter from the FDA regarding modifications in the manufacturing process for which the FDA required additional information. Merit complied by filing a new 510(k) submission.

Merit discontinued sales of the Merit Laureate® during the review period in the United States, but continued to market the product, which is manufactured in Galway, Ireland, in international markets.

“We are pleased to conclude this process and provide this product immediately to our U.S. customers,” said Fred P. Lampropoulos, Merit Medical’s Chairman and Chief Executive Officer. “We believe this segment of the guide wire business offers substantial opportunity and intend to introduce additional hydrophilic wires upon regulatory clearance in the near future.”

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 165 individuals. Merit employs approximately 2,700 people worldwide with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Copenhagen, Denmark; and Rockland, Massachusetts.

Source : http://investor.merit.com/phoenix.zhtml?c=65799&p=RssLanding&cat=news&id=1737652

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High Resolution Calibrated Medical Displays on the Cheap with PerfectLum Software

High Resolution Calibrated Medical Displays on the Cheap with PerfectLum Software

Wilmington, DE, USA – QUBYX Software Technologies Inc., an expert in color calibration and medical imaging fields, has announced that their bundle of the premium DELL UltraSharp U3011 display and PerfectLum 3.0 DICOM calibration software has received the Food & Drug Administration 510(k) market clearance for diagnostic reading, which allows the company to position the device as a professional medical one.

“We are very pleased to have now not only European CE Mark for PerfectLum software, but also the FDA clearance for the DELL 4 MP display and PerfectLum bundle,” says Marc Leppla, Director of QUBYX. “The FDA clearance allows the bundle to officially enter the US and international markets as a medical device. Moreover, it will ensure confidence in quality and safety of the device for healthcare facilities, relying on FDA 510(k) clearance when purchasing medical monitors.”

The DELL UltraSharp U3011 is a 30-inch 4MP display with a resolution of 2560×1600 pixels, a typical brightness of 370 cd/m2 and IPS (in-plane switching) panel technology. The display is designed to provide more consistent colors, a brighter picture from different angles and brilliance across the color spectrum. It allows the user to experience lifelike visuals at 117% (CIE 1976) typical color gamut and to see more detail in grayscales. Multiple connectivity thanks to DisplayPort, two HDMI 1.3 and two DVI-D connectors is also one of UltraSharp U3011 remarkable features.

The medical monitor calibration application PerfectLum 3.0 allows to use this high quality display for viewing of medical images and diagnostics. The UltraSharp monitor in bundle with PerfectLum is delivered calibrated to DICOM GSDF part 14 standard. Moreover, the medical display QA tool allows performing not only DICOM, Gamma and CIE L* hardware re-calibrations using the 10 Bit LUT (Look Up Table) of the display, but also DICOM, AAPM TG18, DIN 6868-157, DIN 6868-57 conformance tests, verification of white level, luminance level and display uniformity. Such PerfectLum features as calibration of multiple displays, connected to one workstation, and remote display management system for maintenance of multiple workstations from one location will be beneficial to networks of healthcare facilities and telemedicine.

The FDA certification for the DELL UltraSharp-QUBYX PerfectLum bundle proves the companies’ commitment to medical imaging field. It also provides evidence of the concept, that commercial displays can be calibrated to meet the highest demands of medical industry and successfully utilized for diagnostics and reviewing of medical images.

About DELL

DELL Inc. is an American multinational information technology corporation based in Round Rock, Texas, United States, that develops, sells and supports computers and related products and services. Bearing the name of its founder, Michael Dell, the company is one of the largest technological corporations in the world. Today, Dell connects with more than 5.4 million customers every day — by the phone, in person, on the company website and, increasingly, through social networking sites. To read more about DELL, please visit DELL Displays Website.

With PerfectLum 3.x medical display calibration software you can calibrate any premium LCD display to the highest medical standards. PerfectLum Suite medical monitor quality control tool not only does the calibration, but also performs quality assurance tests to ensure your display conforms to the most demanding standards of the industry.

The resulting image quality matches and can even surpass that of the most overpriced displays on the market.

ANY GRAPHICS CARD

PerfectLum Suite medical monitor calibration and QA application is compatible with any graphics card, including 13 bit Matrox and 10 bit RealVision medical graphic boards.

ANY MEASURING DEVICE

If you already have a measuring device, you probably won’t need another. PerfectLum Suite medical monitor qualtity control tool works with nearly every model ever made.

AUTOMATIC DISPLAY ADJUSTMENT

On VESA DDC/CI-compliant displays, PerfectLum Suite automatically adjusts contrast and brightness over the DDC/CI channel so you don’t have to go into the display’s OSD menu.

The display is automatically adjusted to a desired white level and optimum color temperature to ensure fast and easy calibration process as well as high quality results.

EXTREMELY PRECISE CALIBRATION

Color calibration is performed not only on white but all gray levels. For example, white will be at 6500 Kelvin, but so will gray 120/120/120 and 64/64/64. This ensures that the observer sees the gray levels correctly, as the aspect of an image is infuenced by colors in the grays, not just luminance.

Medical monitor calibration and QA application PerfectLum

In the process of calibration an ICC profile is generated to save characteristics of colors for the given device.

GLOBAL STANDARDS

PerfectLum medical monitor calibration application calibrates to international standards including NEMA DICOM part 14 GSDF, AAPM TG18, DIN 6868-57, DIN 6868-157, JESRA X-0093 and IEC 62563-1. PerfectLum Suite medical display QA software not only calibrates a display, but also performs acceptance and constancy tests to verify that the display conforms with these standards.

HARDWARE CALIBRATION

Rather than saving on your computer’s graphics card, LUT (Look Up Table) calibration is saved inside any supported display.

UNIFORMITY CORRECTION

For example, if your display is 30% off in luminance from the center, PerfectLum can correct that down to 3%. A display with a nonuniformity of more than 15% can no longer be used in Germany, as it would not meet the German DIN 6868-57 standard. Calibrate with PerfectLum and simply continue using the display.

PERFECTLUM REMOTE

DISPLAY MANAGEMENT

With PerfectLum Remote display management system, a system administrator can perform calibration, verification and quality assurance tests for all displays in multiple hospitals and radiology practices from a single location. The system administrator can schedule further quality assurance tasks for client machines, and a notifier on the client machine will remind the user to perform the task when it is due. An automatic alert system notifies the administrator via e-mail whenever a calibration or a QA test on one of the client machines is failed.

HISTORY DATABASE AND REPORTS

PerfectLum Suite provides proof of maintenance for all your diagnostic displays. After calibrating or using the history feature to visualize previous calibrations and verifications, simply export the report as a pdf, print and file. Automatic backup is performed for history database to ensure not a letter is lost.

Proper medical displays from big names in the business typically cost many thousands of dollars. They are well tuned, often have nifty features like popup calibrating sensors, and adjustment for ambient lighting. But not everyone wants to spend $5,000 on a screen.

PerfectLum is a piece of software from QUBYX, a company out of Nice, France, that through calibration effectively turns a high end consumer monitor into a perfectly compliant medical display. Not that many of the available displays on the market are compatible, but the FDA just cleared the $1400 Dell 30 inch UltraSharp U3011 to be a proper medical display when used with PerfectLum 3.0 DICOM calibration software. It features a resolution of 2560×1600 pixels, a typical brightness of 370 cd/m2 and IPS (in-plane switching) panel technology.

Source : http://www.qubyx.com/us/pressproof-display-calibration/124-qubyx-receives-fda-510k-clearance-for-the-dell-ultrasharp-u3011-with-perfectlum-bundle

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Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe

Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe

Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe

New System Designed for Patient Safety, Ease of Use During Open-Heart Procedures

MINNEAPOLIS – September 24, 2012 – Medtronic, Inc. (NYSE: MDT) today announced Conformité Européenne (CE) Mark for its new Affinity Fusion® oxygenation system in Europe. This system, which is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for patient safety and ease of use. Notably, system enhancements are designed to prevent and remove air bubbles that can enter the blood during the procedure, which may reduce the risk of stroke.

The Affinity Fusion oxygenation system’s new design enhancements include:

A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood;

Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure;

Enhanced setup and customization capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.

“The new Affinity Fusion oxygenator is designed to provide perfusionists with the most innovative and enhanced product of its kind,” said cardiac surgeon Dr. John Liddicoat, senior vice president and president of Medtronic’s Structural Heart division. “With so many patients who undergo cardiac surgery each year, Affinity Fusion provides patients with a reliable oxygenation system they can count on.”

The Fusion oxygenation system is used by perfusionists during open-heart surgical procedures that require a bloodless, motionless surgical field, such as lifesaving cardiopulmonary bypass surgery. As temporary “lungs,” the system adds oxygen and removes carbon dioxide from the blood. This year, cardiopulmonary bypass will occur in roughly 1 million patients worldwide1. The development process of the Fusion oxygenator included extensive collaboration between Medtronic engineers and more than 500 perfusionists worldwide.

“During cardiopulmonary bypass, it is imperative that the equipment is designed to maximize patient safety, yet is also sophisticated, versatile and simple to use,” said Simon Phillips, chief clinical perfusionist at St George’s Hospital in London. “Being part of the collaboration process during the Affinity Fusion oxygenation system development, I am confident that this new technology will benefit patients who undergo these lifesaving procedures and the surgical teams that use it.”

The Affinity Fusion oxygenator is not available in the United States, but Medtronic plans to submit an application for U.S. clearance.

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Medtronic has received the CE Mark for the Affinity Fusion, a system for oxygenating blood and removing CO2 during open heart surgeries. The company spent considerable effort designing the device to minimize the formation of air bubbles in the oxygenated blood that can lead to dangerous side effects like stroke.

Medtronic is planning on submitting papers to the FDA to seek approval for the Affinity Fusion in the U.S.

New features from the announcement:

A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood;

Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure;

Enhanced setup and customization capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.

Source : http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1348163679308&lang=en_US

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