Author’s Note: For this inaugural article I begin with an insider’s look on the “health” of drug-eluting stents and what lies ahead for this much-debated device.

Feb. 7, 2007 — Cardium Therapeutics and its operating unit InnerCool Therapies have announced they will launch two next-generation systems for patient temperature modulation. Both solutions are expected to be cleared and commercially available within the next two quarters, the companies report.

The rapidly advancing field of patient modulation focuses on improving outcomes following major medical events such as stroke, cardiac arrest and heart attack, as well as on the management of patients experiencing trauma or fever.

Feb. 7, 2007 — Cardiologists at the University of Mississippi Medical Center are pioneering the use of an implanted, state-of-the-art cardiac resynchronization therapy device (CRT) that employs radio frequency technology to monitor the cardiovascular status of heart failure patients from their homes.

UMC cardiologists can connect with patients directly and get up-to-the-second information about their heart status from miles away. The physicians can also use the remote monitoring device to automatically obtain and record precise blood pressure and weight measurements.

Feb. 7, 2007 — A first ever human procedure in Madrid took place this week in which a heart failure patient received adult stem cells removed from his own adipose (fat) tissue by liposuction. The cells were processed and injected directly into the heart muscle with a special catheter.

Feb. 7, 2007 — Abbott has announced its plan to launch the world's first drug-eluting stent clinical trial solely in women. Performance of the Xience V Everolimus Eluting Coronary Stent System will be the focus of the SPIRIT WOMEN trial, designed specifically to study CVD in women and how it differs from men. Xience V is not FDA cleared for commercial sale in the U.S.

The first interwoven nitinol self-expanding stent available in the U.S. for palliative treatment of malignant strictures in the biliary tree, the SureSave Stent will be renamed SUPERA. SUPERA represents an advance over traditional laser cut nitinol tube stents in offering more than 360 percent greater radial strength than the next strongest offering. The increase in radial strength is due to the product's interwoven nitinol wire design.

Rapidly cooling a patient's core temperature, the ThermoSuit System consists of a disposable body suit and a means to pump coolant within the suit over the skin of the patient.

It is the first device for patient temperature management that provides a thin layer of rapidly flowing liquid coolant in direct contact with the skin.

The FDA has cleared St. Jude Medical’s Reflexion Spiral Variable Radius Mapping Catheter featuring a circular loop at the tip that expands from 15 mm to 25 mm to fit a variety of patient anatomies. It is the only variable radius circular mapping catheter available with bi-directional deflection, which provides enhanced versatility for complex left atrial procedures. It also features the proprietary ComfortGrip handle to give physicians improved comfort and control during electrophysiology (EP) procedures.

The new AngioJet Ultra Thrombectomy System is a next-generation, completely re-engineered version of Possis' AngioJet Rheolytic Thrombectomy System. AngioJet is marketed for blood clot removal (thrombectomy) from arterial and venous blood vessels.

A low osmolar, nonionic, iodinated contrast agent, the OMNIPAQUE has been used in more than 250 million patients worldwide. Its indications include a broad range of intravascular diagnostic procedures such as coronary angiography, spinal cord imaging and body cavity procedures including shoulder and knee joints. The injection is approved for use in adults and children.

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