May 4, 2012 - SMT Research & Development Ltd. (SMT) announced the addition of three key executives to its management team, including a new CEO, CFO and chief medical officer, plus two additions to its board of directors. The company also announced that its shareholders and board of directors have approved the company's name change to Keystone Heart Ltd.

May 4, 2012 - The U.S. Food and Drug Administration (FDA) has approved the premarket approval application (PMA) for the Medinol Ltd. Presillion plus cobalt chromium (CoCr) coronary stent on a rapid exchange delivery system. This device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length < 30 mm) with a reference vessel diameter of 2.5 to 4 mm.

May 4, 2012 - Medtronic Inc. announced six-month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension. These data presented at the European Society of Hypertension annual meeting showed patients (n=84) who received renal denervation treatment with Symplicity experienced a mean blood pressure reduction of -28/-10 mm Hg (p<0.001) at six months following treatment compared with baseline. No evidence of renal impairment was observed and renal function measures remained unchanged.

May 2, 2012 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) approval of the new advanced GlideLight Laser Sheath for removal of cardiac leads.

May 2, 2012 — St. Jude Medical Inc. yesterday released its biannual product performance report (PPR) on its website, updating the performance of all the company’s cardiac rhythm management devices, including actively-monitored registry data that supports the safety and reliability of the current-generation Durata lead with Optim insulation. The report also provides a new, expanded analysis specifically addressing the performance of the company’s high-voltage leads.

May 2, 2012 — Vessix Vascular Inc. announced this week that it has received CE mark approval for its V2 Renal Denervation System for the treatment of hypertension. Renal denervation is a percutaneous catheter-based therapy that uses RF energy to disrupt renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure.


May 1, 2012 – The Centers for Medicare and Medicaid Services (CMS) announced today it will now cover transcatheter aortic valve replacement (TAVR) for Medicare patients under certain conditions. The coverage decision announced by CMS Acting Administrator Marilyn Tavenner offers important new technology to some of Medicare’s sickest patients.
Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now