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January 9th – January 15th

January 9th: AngioScore Receives Premarket Approval (PMA) for AngioSculpt(R) Scoring Balloon Catheter

AngioScore, Inc, a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced today that its flagship product, the AngioSculpt® Scoring Balloon Catheter, has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

PMA approval allows AngioScore to begin marketing the AngioSculpt in the U.S. for the treatment (as indicated) of coronary artery disease (CAD), one of the largest opportunities in the medical device market. More than one million coronary angioplasty procedures are performed in the U.S. each year, with an additional 1.5 million procedures performed worldwide. In 2005, AngioScore obtained FDA 510(k) clearance to market the AngioSculpt in the U.S. for balloon dilatation of lesions in infra-popliteal arteries, one of the key segments of the rapidly growing peripheral artery disease (PAD) market. In addition, the company has also been granted the CE Mark for the AngioSculpt allowing the product to be sold in Europe and the Middle East.

The AngioSculpt represents a significant improvement in the state-of-the-art for both coronary and peripheral angioplasty catheters. A semi-compliant angioplasty balloon is surrounded by a unique scoring element which works in tandem with the balloon to deliver a "scoring" effect to the target lesion upon balloon inflation. As the balloon inflates, the radial forces are concentrated along the surfaces of the nitinol scoring element. This results in luminal expansion that is precise, predictable and controlled. Barotrauma is reduced resulting in lower dissection rates. Device slippage, which is commonly seen with traditional balloon catheters and may result in "geographic miss", is eliminated with the AngioSculpt.

The U.S. multi-center clinical trial was a prospective study evaluating the safety and effectiveness of the AngioSculpt in 200 patients with single or multiple vessel coronary artery disease, in both de novo lesions and in-stent restenosis lesions. The study's principal investigator was Martin B. Leon, M.D., Professor of Medicine at Columbia University and Chairman of the Cardiovascular Research Foundation (CRF). The participating study sites included nine of the leading interventional cardiology centers in the U.S.: Columbia University Medical Center, Minneapolis Heart Institute, Scripps Clinic and Research Foundation, Swedish Medical Center, Brigham and Women's Hospital (Harvard Medical School), Stanford University Medical Center, University of Oklahoma, Washington Adventist Hospital, and the Washington Hospital Center.

January 10th: Vidacare's EZ-IO(R) Product System Receives FDA Clearance for Distal Tibia Access

Vidacare®, manufacturer of the EZ-IO® product system, the leading solution for immediate vascular access when conventional IV access is challenging or impossible, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the EZ-IO product system for access in the distal tibia for both adult and pediatric patients.

The EZ-IO provides an immediate, safe and secure method of accessing the circulation through the intraosseous (IO) route, a technique that is being used by an increasing number of emergency care personnel for resuscitation and stabilization. IO infusion accesses the central circulation through blood vessels within the bone marrow that are held open by a rigid, non-collapsible bony wall. Medications administered through the IO route reach the central circulation in about one second, equivalent to the central venous route. Recently published guidelines issued by the American Heart Association recommend that IO be used as a first alternative to peripheral IVs in cardiac arrest.

Distal tibia IO capability provides an EZ-IO insertion site just above the inside of the ankle. This is an especially important area of the body for gaining access to morbidly obese patients. The distal tibia is usually a "thinner" area of the body and will assist emergency medical service (EMS) personnel trying to establish vascular access in these patients when time is critical.

The EZ-IO product system can now be used in this location, as well as the proximal humerus (the shoulder area) for adult and pediatric patients, and in the proximal tibia (the area below the knee) for adult and pediatric patients. FDA approval of the EZ-IO for use in the distal tibia increases options for emergency medical professionals in obese patients, and for the military in their treatment of battlefield casualties.

January 10th: GenesisBPS Announces the North American Distribution and FDA 510K Clearance of the SEPAX Cell Separation System for Cord Blood Processing

GenesisBPS (www.genesisbps.com) has announced that the SEPAX Cell Separation System, developed and manufactured by Biosafe SA (www.biosafe.ch) has received 510(k) marketing clearance from the U.S. Food and Drug Administration's Center for Biologics Evaluation & Research (CBER) for use as a cord blood-processing device.

Cord blood is increasingly used as a source of adult stem cells to treat blood disorders such as leukemia, but also contains somatic cells that have potential in the emerging field of regenerative medicine. Collected immediately after birth, cord blood is sent to public and private banking facilities where it is processed and cryogenically stored until needed. The SEPAX system allows fast, automated, reproducible processing of cord blood in a closed, sterile environment.

Introduced with CE Mark in 2001, the SEPAX System has rapidly gained acceptance within the international cord blood community and is used by a majority of NETCORD members, an association of the largest public cord blood banks in the world. The SEPAX technology is a versatile platform that is able to process various cellular products and is also routinely used in non-US markets for the processing of bone marrow and peripheral blood stem cells.

Claude Fell, President and CEO of Biosafe, said, "The SEPAX System, built around a unique proprietary separation technology, is the only fully-automated system available in the growing market of adult stem cell processing. The FDA 510(k) clearance to market this device in the US is a significant milestone in establishing Biosafe as a global leader in the field of automated cell processing. Biosafe is pleased to be able to offer a safe and reliable processing system at a time when major efforts are being made to increase cord blood inventory in the US.

January 11th: St. Jude Medical Announces FDA Clearance and European Approval of New Electrophysiology Products

St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Reflexion Spiral(TM) Variable Radius Mapping Catheter and a faster, smaller EnSite® System workstation computer.

St. Jude Medical will feature these products for the first time at the Boston Atrial Fibrillation Symposium, a meeting of leading electrophysiologists in the field of arrhythmia and atrial fibrillation (AF) management from around the world. The meeting will be held January 11 - 13, 2007.

The Reflexion Spiral Variable Radius features a circular loop at the tip that expands from 15 mm to 25 mm to fit a variety of patient anatomies. It is the only variable radius circular mapping catheter available with bi-directional deflection, which provides enhanced versatility for complex left atrial procedures. It also features the proprietary ComfortGrip(TM) handle to give physicians improved comfort and control during electrophysiology (EP) procedures.

The EnSite System provides highly detailed, three-dimensional (3-D) cardiac models that help physicians diagnose and treat many arrhythmias, including AF. The System is now available with a new computer, featuring twin dual-core processors for a dramatic improvement in processing speed. Many of the most complex processing and image rendering times have been reduced by up to 80 percent, allowing clinicians to obtain, display and analyze information faster than ever.

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