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.

May 1, 2012 — Theragenics Corp. announced that Galt Medical, a wholly-owned subsidiary of Theragenics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Galt VTI valved tearaway introducer.

May 1, 2012 — Cameron Health Inc. announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD (subcutaneous-implantable cardioverter defibrillator) system for the treatment of sudden cardiac arrest (SCA).

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