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September 26 – October 2 

September 26th: U.S. Food and Drug Administration Approves New Medical Devices to Treat Clogged Neck Arteries

Cordis Endovascular, a division of Cordis Corporation, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its PRECISE® Nitinol Stent and ANGIOGUARD® Emboli Capture Guidewire to treat clogged neck arteries, known as carotid artery disease. FDA approval of the Cordis carotid system was announced today at the Vascular Interventional Advances (VIVA) meeting in Las Vegas. Carotid arteries are the main blood vessels leading to the brain. PRECISE® and ANGIOGUARD® are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA) -- a surgical treatment for removing arterial plaque from the carotid artery.

The PRECISE® and ANGIOGUARD® is the only carotid system backed by a large, randomized clinical trial -- the landmark SAPPHIRE study -- to support the potential benefits of carotid artery stenting (CAS) in patients who are ineligible, or considered high-risk, for carotid endarterectomy. The Cordis carotid system has been studied in over 3,000 patients across both SAPPHIRE and the Carotid Artery Stent Education System Post-Marketing Study (CASES(TM)- PMS) and demonstrated low stroke rates in both.

Carotid artery disease is the buildup of atherosclerotic plaque in the major neck vessels delivering blood to the brain, a major cause of stroke. CAS is a non-invasive, non-surgical procedure intended to improve blood flow to the brain while helping prevent debris from entering cerebral circulation, and an important alternative for patients who are ineligible for CEA.

Cordis Endovascular is a recognized leader in endovascular research and development and is committed to serving the cardiology, radiology and vascular surgery communities through the development of groundbreaking technologies for the treatment of peripheral vascular disease.

September 27th: Boston Scientific Announces FDA Approval of Harmony(TM) HiResolution(R) Bionic Ear System

Boston Scientific Corporation (NYSE: BSX ) today announced the approval of its new Harmony(TM) HiResolution® Bionic Ear System (Harmony System) by the U.S. Food and Drug Administration (FDA). Developed by the Company's Neuromodulation Group, the Harmony System delivers 120 spectral bands, 5 - 10 times more than competing systems, helping to significantly increase hearing potential and quality of life for the severe-to-profoundly deaf.

Designed to enhance music appreciation and improve hearing in a variety of difficult listening environments, the Harmony System couples revolutionary internal sound processing (with the optional HiRes Fidelity(TM) 120) with the new Harmony behind-the-ear (BTE) external sound processor. Together, the two key components of the Harmony System are designed to provide significantly enhanced spectral resolution compared to conventional systems for a more natural representation of sound to help improve patient performance.

Cochlear implant users can access soft whispers and loud sounds without adjusting dials or controls with Harmony's CD-quality processing and sophisticated dual-loop automatic gain control, helping users better appreciate music, hear in noisy environments, use the telephone, and hear sounds that are loud and soft.

In addition to the FDA approval, the Harmony HiResolution Bionic Ear System recently received approval from Health Canada and the CE mark in Europe.

According to clinical evaluation results, approximately 80 percent of the subjects reported a strong preference for the Harmony sound processor with HiRes Fidelity 120, most noting that they had improved clarity of speech and/or that environmental sounds were clearer and easier to distinguish.

The HiResolution Bionic Ear System with optional HiRes Fidelity 120 is approved in the U.S. for adults only at this time and for all patients in Canada and Europe. The product is expected to be available in early 2007. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. The Neuromodulation Group is a global leader in the development of implantable, high-technology neurostimulation devices that include treatments for deafness and chronic pain.

October 2nd: CardiacAssist Wins FDA Approval for TandemHeart(R) Escort Controller

CardiacAssist, Inc. has received FDA 510(k) market approval for its new TandemHeart® Escort® Controller.

The new, lightweight, space-saving Escort Controller is one of three primary components that make up the TandemHeart® PTVA® System. The TandemHeart System provides circulatory support through a cardiac catheterization procedure in as little as 30 minutes. It is FDA approved for extracorporeal circulatory support for up to six hours for procedures not requiring full cardiopulmonary bypass.

Weighing only 21 pounds, the Escort Controller replaces the original 93- pound TandemHeart Controller. It can be mounted at bedside, on an IV pole or on a table top. It is intended primarily for AC power use, but has enough battery back-up power for an hour of operation.

The Escort Controller design retains proven subsystems that have been in use for years in the current controller, such as the pump motor driver circuits, flow estimator, air bubble detector, IV pump, and infusion system. Retaining these subsystems maintains compatibility between the two generations of controllers and ensures a high degree of reliability. The TandemHeart System is fully reimbursed by Medicare under existing DRG codes. It can be placed rapidly in the cath lab or operating room, providing reliable extracorporeal circulatory support via percutaneous access.

The TandemHeart System is used in 17 of the top 20 heart and heart surgery hospitals in the U.S. and 11 of the nation's top 14 hospitals overall. To date, more than 700 uses of the system in 28 countries at 70 different facilities by 120 different physicians have been recorded. The TandemHeart System is the only FDA approved device of its kind in the U.S.

Founded in 1996, CardiacAssist, Inc. is a privately held, Pittsburgh-based medical device company that develops, manufactures and markets innovative products designed to provide cardiologists and cardiac surgeons with minimally invasive solutions for providing extracorporeal circulatory support. Its vision is to help advance the treatment of heart disease by bridgi

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