Cardio

Micell Technologies, Inc. is aggressively chasing the Chinese market by entering into an agreement with Hefei Life Science to get its drug eluting stent through clinical studies and on to regulatory approval.

Heart rhythm and home monitoring specialist Biotronik, has gained FDA approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D) devices.

Edwards Lifesciences’ FDA approval for its Sapien Transcatheter Heart Valve was originally limited to transfemoral or transapical access. Now the access point restriction has been lifted, based on clinical registry data. Whether this opens up the patient population remains to be seen.

Earlier this year CardioLogical Solutions was formed from the merger of Emboline and VasoStitch. Now the emerging cardiovascular device company has announced that it has successfully completed in vivo validation of its TAVI access-and-closure device, VasoStitch™.

September 2013 is Atrial Fibrillation Awareness month and heart device company AtriCure, Inc. has taken the opportunity to announce a significant multi-year strategic investment in clinical trial and educational initiatives aimed at reducing the global Atrial Fibrillation epidemic.

Embolic protection stent developer, InspireMD Inc. has announced David Blossom as Vice President of Global Marketing and Strategy. Blossom will be responsible for a global strategic marketing plan that addresses the emerging coronary, carotid and multiple vascular opportunities before the Company.

InspireMD’s embolic protection stent has featured on several occasions on our pages. Newly released quarterly and year-end financials suggest it’s doing the job at sales level and anticipated clinical results should bolster future revenues.

JenaValve’s eponymous TAVI system has seen its CE mark indications extended, making it the only transcatheter valve system approved for the treatment of aortic stenosis and aortic insufficiency.

Boston Scientific Corporation has completed enrollment in the EVOLVE II randomized, controlled clinical trial of its SYNERGY™Stent System. The safety and efficacy study will support U.S. FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.

W. L. Gore & Associates has gained FDA approval for its Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to receive FDA approval for this indication and is designed for multiple thoracic etiologies.

Keystone Heart’s clever filter sits over the aortic cerebral branches during TAVR and other interventional heart procedures, preventing debris from heading north. Now the device, developed in Israel, has gained CE marking and will now be introduced into Europe.

So Direct Flow Medical’s foray into U.S clinicals has begun with the enrollment of a first patient in its Transcatheter valve study. It’ll be interesting to see how this one pans out as the novel design takes on the established metal scaffolds from the early starters.

When things go right, early stage companies like InspireMD eventually have to transition from developers to functioning commercial operations. This means taking a cleaver to operational elements that aren’t essential, so consolidating manufacturing and outsourcing physical distribution.

Apica Cardiovascular has received CE Mark Approval for its platform Access, Stabilisation, and Closure (ASC™) system that allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart

According to global market intelligence company Millennium Research Group, the European market for clot management devices will see moderate growth through 2022. Although a number of segments are mature, fast-growing segments such as endovascular treatments for acute ischemic stroke and venous thromboembolism underpin the growth forecast.

Kips Bay Medical markets in Europe its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting surgery (CABG). It’s clearly aiming for the US but has felt the need to update its shareholders with a status report, which is quite interesting in in itself.