Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, announced regulatory approval from the China Food and Drug Administration (CFDA), South Korea’s Ministry of Food and Drug Safety (MFDS), and the Taiwan Food and Drug Administration (TFDA) for the company’s REVIVE SE Thrombectomy Device, a next-generation self-expanding clot removal device intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease.

Cook Medical has enrolled the first patient in the clinical study in China of its Zilver PTX Drug Eluting Peripheral Stent. The case was performed by one of the study’s principal investigators, Prof. Peng Liu, M.D., at the China-Japan Friendship Hospital in Beijing.

Lombard Medical, Inc., a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAA), today announced that its lead product, Aorfix, an endovascular stent graft to treat AAA, has received approval from the Japanese Ministry of Health, Labour and Welfare. Commercial sales will follow reimbursement approval, which the Company anticipates receiving in September. Aorfix will be exclusively distributed by Medico's Hirata Inc., one of Japan’s leading suppliers of vascular products with proven expertise in building significant market share for AAA stent grafts. Japan is the world’s second largest, standalone EVAR market.

Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway. Eliquis is also approved in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip or knee replacement surgery, and for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.

The Spectranetics Corporation today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance of their peripheral atherectomy products, Turbo-Tandem(R) and Turbo Elite(R), for the treatment of in-stent restenosis (ISR). The clearance prompts a new standard of care in ISR treatment with improved clinical outcomes. 

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, today announced the completion of patient enrollment in the superficial femoral artery (SFA) arm of its BIOFLEX-I clinical trial, an FDA-approved investigative device exemption (IDE) trial evaluating the use of self-expanding nitinol stents in treating peripheral artery disease. A total of 296 patients were successfully implanted with the Astron Pulsar and Pulsar-18 stents at 34 centers in the US, Canada and Europe. 

Demonstrating its continued leadership in the development of innovative solutions for peripheral vascular disease, Boston Scientific Corporationhas received CE Mark for the Ranger Paclitaxel-Coated PTA Balloon Catheter. 

480 Biomedical, Inc. today announced that it has been awarded Phase II funding from the National Heart, Lung, and Blood Institute (NHLBI) to continue the development of a bioresorbable, self-expanding scaffold to treat pediatric pulmonary artery stenosis.