Cook Medical recently announced that the first US patients involved in a Phase II clinical trial of the Zilver PTX Stent were treated at Tri-City Medical Center in Oceanside, CA. The Trial is taking place at 28 US locations and represents the first medical device trial conducted simultaneously in the US and Japan. Based on clinical data results collected, Cook Medical will be seeking regulatory approval in both markets. This stent is intended to treat peripheral arterial disease (PAD), which affects more than 10 million Americans each year. Stent implementation is an exciting option because patients can often avoid surgery and get back on their feet much more quickly after having a stent implanted. It will be interesting to see if the same drug-eluting technology found in cardiovascular stents can be used to treat blockages in arteries outside of the heart – or if any of the long-term clotting concerns will be raised with these products as they have with the cardiovascular stents.
Continue reading "First International Study of Paclitaxel-coated Stent for Use Outside the Heart" »
I’m excited to share the news about PharmaMedDevice On Demand – a new webcast library featuring presentations from the recent PharmaMedDevice Conference in New York.
The library features two complimentary webcasts so listeners can get a sample of the valuable, industry content offered – The Future of Device-Biologics (Presented by AnneMarie Moseley, CEO, Aggregate Therapeutics) – and Bionanotechnology and Drug Delivery (Presented by Raj Bawa, President, BAWA Biotechnology Consulting LLC; Ola Nerbrink, Principal Scientist, Novo Nordisk; and Alan Minsk, Parnter and Leader Food and Drug Practice Team, Arnall Golden Gregory LLP).
Continue reading "PharmaMedDevice On Demand" »
We continue to hear about various medical device and pharmaceutical companies partnering to create innovative new combination projects and drug delivery devices. Recently I read about an exclusive, long-term partnership between Baxter Healthcare Corporation
and Spinal Restoration, Inc. to develop and commercialize Biostat BIOLOGX Fibrin Sealant.
The companies are partnering to create the Biostat Disc Augmentation System – a minimally invasive biologic device used for the treatment of degenerative intervertebral discs. By incorporating a human-based protein polymer (fibrin), these products are expected to stimulate natural tissue growth and wound repair. Spinal Restoration is preparing for an investigational device exemption (IDE) clinical study in the first quarter of 2008.
Continue reading "It’s All About Partnerships…" »
