A Medical Device Daily

A day after Boston Scientific (Natick, Massachusetts) reported lifting warning letter restrictions that had blocked approval of rhythm management products made at its plant in St. Paul, Minnesota (Medical Device Daily, April 17, 2007), the company reported a product approval in its rhythm management line.

It said that the FDA approved the Acuity Steerable left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure. This product features a deflectable tip for precise placement of the lead — even in difficult-to-access branch vessels on the left side of the heart.

A lead is an insulated wire that carries the heart signal to the implanted device and delivers energy from the device to the heart. In most cases, leads are passed into the heart through veins.

The Acuity lead provides physicians with four configurations for stimulating the left side of the heart, which Boston Scientific refers to as electronic repositioning. This ability allows physicians to change the stimulation site non-invasively after implant, which helps avoid the need for an additional surgical procedure.

"The ability to place a left ventricular lead precisely where it will stimulate the heart most effectively is a key factor in providing patients with optimal cardiac resynchronization therapy," said Stephen Mester, MD, medical director of electrophysiology lab, Tampa General Hospital (Tampa, Florida). "The Acuity Steerable lead's deflectable tip control is similar to an electrophysiology catheter and allows me to easily maneuver it into side-branch vessels."

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