May 29, 2007 — Abbott announced Friday, May 25, that it has initiated a voluntary, nationwide recall of its ARCHITECT STAT Troponin-I diagnostic test. The product was distributed to clinical laboratories both in the U.S. and abroad, and is used to aid in the diagnosis of injury to heart muscle and/or heart attack.

No patient injuries have been reported. Laboratories may continue to use the product with the updated directions for use, which Abbott is distributing to clinical labs.

May 23, 2007 — XTENT Inc. announced positive six-month follow-up data from the CUSTOM II clinical trial, which assessed the safety and efficacy of the company's investigational Custom NX drug-eluting stent (DES) system for the treatment of long and multiple lesions in patients with coronary artery disease. Results were presented during the EuroPCR Meeting taking place this week in Barcelona.

May 23, 2007 — MicroMed Cardiovascular Inc. has announced that on Monday, May 14, 2007, doctors at Freeman Hospital in Newcastle upon Tyne, England, successfully implanted the latest design DeBakey VAD "X2" pump in a 59-year-old man.

"I'm proud to say that yesterday we implanted a MicroMed Cardiovascular, Inc. DeBakey ventricular assist device in a patient with severe ischemic cardiomyopathy and he's doing very well,” said the implanting surgeon, Dr. Stephen C. Clark. “Less than 24 hours after the surgery the patient is awake and alert and is quite happy with the results,"

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.

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