Feb. 23, 2007 — The first patient implant was performed this week in a feasibility study evaluating the use Medtronic’s Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System to treat patients requiring congenital pulmonary heart valve replacement.

The prospective, non-randomized, feasibility clinical trial will enroll 30 patients at three U.S. medical centers including:

• Children's Hospital Boston (Boston, MA) with investigators James Lock, M.D. Cardiologist-in-Chief and Emile Bacha, M.D. Senior Associate in Cardiac Surgery

Feb. 23, 2007 — Heart device maker Edwards Lifesciences Corp. received a warning this week from the FDA about the quality-systems handling at its California facility, the Wall Street Journal reported. In the warning FDA told Edwards the company will not be receiving FDA premarket approval for devices "reasonably related to those issues."

According to Edwards CEO Michael A. Mussallem, the company is fully committed to quickly resolving the issues and does not anticipate the matter to have a material impact on its 2007 financial strength and direction.

Feb. 23, 2007 — Cordis Corp. introduced the REGATTA Steerable Guidewire family of devices in the U.S. this week, which 12 selections of the REGATTA Steerable Guidewire and two choices of the REGATTA SB Steerable Guidewire. In April, the company plans to add the REGATTA HS Steerable Guidewire in two selections.

Feb. 23, 2007 — Philips has announced availability of its new HeartStart MRx monitor/defibrillator with capability to network with the Philips IntelliVue Clinical Network. The design enables the device to serve as a wireless transport monitor/defibrillator or cardiac bedside monitor/defibrillator with built-in pacing, synchronized cardioversion and defibrillation capabilities.

FDA has granted approval to the Cordis Endovascular division of Cordis Corp. to market its PRECISE RX Nitinol Self-Expanding Stent and ANGIOGUARD RX Emboli Capture Guidewire System to treat clogged neck arteries. The approval was announced during the Arizona Heart Institute's International Congress on Endovascular Interventions in Scottsdale, AZ.

For all the potential patient safety good that is promised by healthcare’s widespread embracing of electronic health records (EHR), as well as the hoped-for harmony of hospital information systems happily humming a unified tune across vendor brands, the reality of sluggish adoption still plagues the industry. Hospital IT executives continually point to financial constraints as the No.

Feb. 16, 2007 — Congressional staff members were informed about the latest advances in cardiac care for women early this week. The Society for Women’s Health Research convened cardiovascular experts on Capitol Hill to report on leading edge imaging techniques and heart-assisting devices.

Feb. 16, 2007 — A Florida State University researcher has collaborated in a research project that could lead to ways of producing even sharper medical images than those produced with MRI.

Naresh Dalal, professor of Chemistry and Biochemistry at FSU, recently conducted experiments with other researchers from FSU, the University of Colorado and the National Institute of Standards and Technology NIST) that uncovered unique properties in a molecular magnet — properties that could significantly increase the resolution of MRIs.

Feb. 16, 2007 — Intravascular ultrasound innovator Volcano Corp. announced this week it has selected Cordis Endovascular Systems Japan to be its distributor of IVUS products for use in peripheral and endovascular procedures in that country. A letter of agreement has been signed with Cordis parent company Johnson & Johnson K.K., Medical Company.

Positive AAA Results with Endovascular Approach

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