May 23, 2007 — InspireMD has announced this week the enrollment of 19 patients in its First in Man study in a multicenter registry of percutaneous coronary intervention performed with the MGuard coronary stent at the Heart Center in Siegburg, Germany.

MGuard Coronary Stent is designed to provide embolic shower protection during and post procedure. It is under investigation to treat patients with coronary and SVG disease.

May 23, 2007 — MedicalCV Inc. has announced that the United States Patent and Trademark Office ("USPTO") has issued three additional Notices of Allowance to MedicalCV on patent applications pertaining to various aspects of MedicalCV's proprietary laser-based surgical ablation technology. MedicalCV currently markets both the ATRILAZE and SOLAR Surgical Ablation Systems.

May 22, 2007 — Luna Innovations has announced it has received a market clearance letter in response to its 510(k) application to the FDA for the EDAC (Emboli Detection and Classification) QUANTIFIER, a cardiopulmonary bubble detector that uses quantitative ultrasound technology to noninvasively detect gaseous emboli in an extracorporeal bypass circuit line.

Luna says it will market and sell the EDAC QUANTIFIER for clinical use in the U.S.

May 21, 2007 — Findings presented last week during the annual meeting of the Heart Rhythm Society in Denver indicate a common stress test, using GE Healthcare’s latest algorithm for the measurement of T-wave Alternans (TWA), can be useful in predicting sudden cardiac death, even in those without a previous heart attack or symptoms of heart failure.

May 21, 2007 — OrbusNeich announced today it has received CE Mark approval for three interventional cardiology products: the Blazer cobalt chromium stent, the Sapphire PTCA dilatation catheter and the Lumina 6F guiding catheter.

May 21, 2007 — Sanofi-aventis has announced that the FDA has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox (enoxaparin sodium injection) for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI). Lovenox has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI).

May 18, 2007 — According to a report published Thursday in the Wall Street Journal and posted on UPI, the number of coronary stents implanted in patients at U.S. hospitals dropped more than 15 percent in April compared with the number of such procedures performed in April 2006. Stenting procedures at 140 hospitals totaled about 71,200, according to a poll done by the Toronto-based Millennium Research Group, the newspaper reported.

The steep decline in stent use may have been prompted by data from the COURAGE study presented at ACC in March.

May 18, 2007 — Hansen Medical Inc. said Thursday it obtained approval in the European Union for its Sensei robotic catheter system and Artisan catheter, which allows the company to begin marketing the system in the EU.

Mountain View, CA,-based Hansen is a developer of robotic technology for control of catheter movement during cardiac procedures.

May 18, 2007 — Inverness Medical Innovations Inc. and Biosite Inc. have announced the companies have entered into a definitive merger agreement under which Inverness will acquire all of Biosite’s outstanding common stock not already owned by Inverness in a cash tender offer for $92.50 per share.

May 18, 2007 — Medicure, a biopharmaceutical company focused on the research, development and commercialization of novel compounds to treat cardiovascular disorders, is developing MC-1 for the treatment of acute ischemia and ischemic reperfusion injury, and has received a Fast Track Designation from the FDA for the drug.

Currently, MC-1 has completed two positive Phase 2 studies, one in angioplasty patients and most recently a 901-patient coronary artery bypass graft (CABG) study, called MEND-CABG.

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now