Boston Scientific has won U.S. Food and Drug Administration approval for a unique heart defibrillator with leads that can be implanted just under the skin instead of connected directly into the heart.

The regulatory win triggers a $150 million payout to the former owners of Cameron Health, a privately held company Boston Scientific bought March. It also opens the door to an additional $1.05 billion in potential payments upon achievement of revenue-based milestones over the next six years.

At the time of the acquisition, Boston Scientific CEO Hank Kucheman said the deal was introducing innovation into the cardiac rhythm management space and represented an important part of Boston Scientific’s strategy to generate top-line revenue and market share growth.

The defibrillator allows doctors to implant it without accessing a patient’s blood vessels or heart. Instead, the subcutaneous implantable defibrillator uses a wire implanted just under the patient’s skin to help to restore regular heart rhythms when sudden, abrupt loss of heart function hits. The system has already received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009.

The new defibrillator system provides an alternative for patients with life-threatening heart arrhythmias for whom the routine implantable cardiac defibrillator placement procedure isn’t ideal, says Christy Foreman, director of the FDA’s Office of Device Evaluation. “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.”

The FDA approved the system to provide an electric shock to the heart when a patient’s heart is beating at a dangerous level or abnormally fast. It is approved only for patients who do not require a pacemaker or pacing therapy.

As part of the approval, the FDA is requiring Boston Scientific to conduct a postmarket study to assess the long-term safety and performance of the device and to assess differences in its effectiveness across genders. That study will follow 1,616 patients for five years.