Fri Sep 28, 2012 5:26pm - U.S. health regulators approved Boston Scientific Corp's first-of-its-kind heart defibrillator that does not require leads to be inserted into the heart.
Defibrillators help control heart rhythm by applying an electric shock to the heart when it beats abnormally fast, reducing the risk of cardiac arrest.Traditional defibrillators require electrical conductor wires or leads to be inserted into the heart through a vein in the upper chest.
Boston Scientific's Subcutaneous Implantable Defibrillator (S-ICD) requires the wires to be implanted under the skin along the bottom of the rib cage, making the procedure accessible to more patients.
It is the first such device to get approval from the U.S. Food and Drug Administration. The S-ICD System is commercially available in many countries in Europe, as well as New Zealand.
"Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device," FDA official Christy Foreman said in a statement.
The device is manufactured by Cameron Health Inc, which was acquired by Boston Scientific in June.
The FDA said it requires Cameron Health to conduct a postmarket study to assess the long-term safety and performance of the device.
Shares of Boston Scientific closed at $5.74 on Friday on the New York Stock Exchange.