May 29, 2007 — The Centers for Medicare & Medicaid Services (CMS) announced on May 25 a decision to provide coverage for Doppler monitoring of cardiac output in certain settings, removing the past noncoverage of this diagnostic test in these settings and adopting an evidence-based approach to healthcare.

May 29, 2007 — Boston Scientific Corp. has received CE Mark for its TAXUS Liberte Long paclitaxel-eluting coronary stent system, allowing doctors to treat longer coronary artery lesions with a single stent. TAXUS Liberte Long is the longest available drug-eluting stent.

May 29, 2007 — The FDA has cleared the CORDIS ENTERPRISE Vascular Reconstruction Device and Delivery System under the Humanitarian Device Exemption — it is used with embolic coils for the treatment of intracranial aneurysms. It consists of a self-expanding stent and a delivery system. The stent serves as a scaffold for embolic coils to prevent herniation of the coils into the parent vessel.

May 29, 2007 — Orqis Medical Corp., a clinical-stage company developing devices for the treatment of congestive heart failure (CHF), has announced that the 150th patient has been enrolled in the MOMENTUM Pivotal Trial. With 200 patients needed for study completion, the trial is now 75 percent enrolled.

The MOMENTUM Pivotal Trial is studying the use of the company's percutaneous Cancion System in heart failure patients. The novel Cancion System is designed to treat patients hospitalized with decompensated heart failure who inadequately respond to medical therapy.

May 29, 2007 — Doctors at University of Pittsburgh Medical School, (UPMC) have begun a study using an investigational cardiac device, the VentrAssist, Left Ventricular Assist System (LVAD) to see whether it can be used safely and effectively in patients with end-stage heart failure.

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.

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