FDA approves Boston Scientific's unique heart device

• Implantable device does not directly touch heart 
• Natick, Mass.-based Boston Scientific Corp. acquired the device through a $150 million buyout of San Clemente, Calif.-based Cameron Health. Under the terms of the deal, Boston Scientific will pay an additional $150 million for FDA approval, plus up to $1 billion in payments based on future sales figures.

(Reuters) - 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.

Similar to transvenous ICDs, the subcutaneous ICDs are designed to provide lifesaving defibrillation therapy whenever it is needed. In contrast, the subcutaneous ICDs do not require electrical wires inside the venous system.

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.