May 29, 2007 — Medtronic Inc. has enrolled the first patient in the landmark PROTECT clinical study, the largest randomized trial focusing on the safety of drug-eluting stents (DES).

The 8,800-patient trial will compare the Medtronic Endeavor zotarolimus-eluting coronary stent system and the Johnson & Johnson Cypher sirolimus-eluting stent, using key safety endpoints and other clinically relevant outcomes. The first patient was implanted in Germany.

May 29, 2007 — The FDA has cleared the Mynx VCS vascular closure system (VCD) by AccessClosure designed to seal a puncture site in the femoral artery and stop the bleeding after a cardiac catheterization procedure.

The Mynx VCS uses a balloon catheter and a standard procedural sheath to deliver an extravascular, hydrogel sealant used to seal the puncture site. Following the cardiac catheterization procedure, the Mynx VCS balloon catheter is inserted through the introducer sheath into the femoral artery to temporarily stop bleeding at the puncture site.

May 29, 2007 — Abbott announced positive results last week from ABSORB, the world’s first clinical trial evaluating the safety and performance of a fully bioabsorbable drug eluting stent platform for the treatment of coronary artery disease.

May 29, 2007 — Agfa HealthCare, a leading provider of IT enabled clinical workflow and diagnostic imaging solutions, has unveiled ORBIS, its Hospital and Clinical Information System (HIS/CIS), for the first time in Canada at the e-Health Conference 2007

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.

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