FDA Approves Boston Scientific’s New Heart Failure Lead
April 18, 2007 — Boston Scientific Corp. says the FDA has cleared the new Acuity steerable left ventricular lead device, for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.
The product, which the company plans to launch in July, features a deflectable tip for precise placement of the lead even in difficult-to- access branch vessels on the left side of the heart, the company said in a statement.
The approval notice comes just a day after Boston Scientific announced FDA officials had lifted all restrictions at the company's Guidant plant in Minnesota.
For more information visit www.bostonscientific.com.