The sheer number of devices involved in the care of critically ill patients can be staggering and includes ventilators, multiple infusion devices, physiologic monitors, point-of-care testing devices, intermittent compression devices, hypo/hyperthermia units and equipment used for management of clinical information — to mention a few.

Only a marketing director for stretchers could draw a parallel between a nurse and an auto mechanic.
“Have you ever watched somebody push a stretcher?” asked Don Payerle from Stryker Medical. “They lean into it — kind of like getting an old Chevy going. Once it rolls, it's not nearly as hard to keep going, but the first steps are where they really have to put their backs into it.”

April 11, 2007 — FDA has released the following Q&A from Boston Scientific Tuesday.

On April 5, Boston Scientific/Guidant recalled approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty capacitor in these devices can cause the batteries to deplete sooner than expected. Most patients will not be affected by this recall, but patients with one of the recalled devices should contact their physicians about what steps to take next. Please see the questions below for additional information.

April 11, 2007 — Kensey Nash Corp. has announced it has received CE Mark approval to expand the indication for the third generation of its embolic protection technology, known as the TriActiv ProGuard System, for use in the carotid anatomy.

The new indication is significant for the Kensey Nash device in the European marketplace because the use of embolic protection devices is very prominent in carotid stenting procedures. The company had launched the TriActiv ProGuard System in Europe for use in saphenous vein graft procedures last year.

April 10, 2007 — University of California San Diego Medical Center cardiology and neurology specialists are using a novel method to save the lives of patients in cardiac arrest.

Using an innovative technology that rapidly cools the blood, the body temperature of the cardiac arrest patient is lowered, protecting the brain from damage that can result immediately after a heart attack.

Adopted at UCSD Medical Center in October 2006, the technique has been used to save multiple lives and is being implemented at hospitals worldwide.

April 10, 2007 — CryoCor Inc., a medical device company focused on the treatment of cardiac arrhythmias, has announced it was informed by the FDA that the agency will convene an Advisory Panel meeting to review CryoCor's pre-market approval application, or PMA, for the treatment of atrial flutter. The Advisory Panel meeting is expected to be held in June or July 2007, and a decision from the FDA on CryoCor's PMA is expected in August 2007.

The Impella 2.5 circulatory support system, by Abiomed Inc. was among 35 innovative healthcare products to receive a 2007 Medical Design Excellence Award — MDEA is the premier awards program for the medical technology community.

April 10, 2007 —Boston Scientific Corp. has begun notifying physicians some of its implantable heart defibrillators contain batteries that could deplete early, shortening the life span of the devices, Reuters reported.

In an April 5 letter to doctors posted on Web site of its Guidant unit, the company stated that there have been no patient deaths or serious injuries associated with the battery voltage problem.

April 9, 2007 — The FDA has approved Abbott's new coated Niaspan (niacin extended-release tablets) for boosting HDL cholesterol -- the "good" cholesterol.

Niaspan is the only FDA-approved, once-daily extended-release prescription niacin formulation for the treatment of lipid disorders with an ability to significantly raise HDL cholesterol.

April 9, 2007 — MIV Therapeutics Inc. has announced that its recent bench test confirmed that merging Biosync Scientific's certified bare metal stent platform (which MIVT recently acquired) with its own polymer-free drug delivery system met critical "FDA Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" requirements for in vitro mechanical fatigue testing.

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