In short
Founded in 2004 by two cardiologists, Galway, Ireland-based Cappella Medical Devices Ltd (Cappella), proudly claims to be the world’s leading cardiology technology company, which remains open to debate with one or two other candidates. However what’s undoubtedly true is just how clever their technology is, as seen most notably in their flagship Sideguard® Coronary Stent System designed to address disease at bifurcations of the coronary arteries. The company has now announced that following the gaining of CE approval in 2009 it has received regulatory approval in India for Sideguard.
Background
Up to 30% of all Percutaneous Coronary Interventions (PCI) include bifurcation disease. ccording to a company press release from Cappella Medical Devices Ltd, Sideguard incorporates the company’s proprietary stent design and balloon delivery system, offering the interventional cardiologist a solution that, for the first time, provides ostial protection and side branch preservation, thereby enabling enhanced care for patients across a wide range of bifurcation lesions.
The Cappella Sideguard system is currently CE mark approved and is being distributed throughout Europe, South America, and Canada.
Company comments
David Blossom, VP of Commercial Operations for Cappella said, “This regulatory approval in India represents an important milestone for Cappella Medical. Treating bifurcation disease has always been a challenge for physicians due to the complex anatomy of the coronary sidebranch and the inability of main vessel and work horse stents to address and protect the unique nature of such vasculature.” He added, “Now, clinicians in India, as in a number of other markets, will be able to use Cappella’s Sideguard system, a technology dedicated to bifurcation disease that scaffolds the ostium reducing plaque and carina shift while preserving the sidebranch. India is an important growing, yet underserved, market and Cappella looks forward to introducing its device and technology to clinicians throughout the country.”
SOURCE: Cappella Medical Devices Ltd., Business Wire
published: March 4, 2012 in: Approval/Clearance, Cardio, Regulatory