Cameron Heart Device Gets FDA ApprovalMonday, October 1, 2012
An implantable heart defibrillator made by San Clemente-based Cameron Health Inc. has been approved by U.S. Food and Drug Administration.
Cameron was acquired by Natick, Mass.-based Boston Scientific Corp. in March in a deal that could be worth up to $1.35 billion, depending on regulatory milestones.
Boston Scientific shares are about steady in trading today, with a market value of about $8 billion.
Cameron’s S-ICD implantable defibrillator passed its first hurdle with the FDA in April, when the agency’s advisory panel said the benefits of the device outweighed its risks.
The device is placed under the skin and provides electric shocks to interrupt abnormal heart rhythms and return them to normal pace. It’s distinguished by its lack of intravenous wires that go into a patient’s veins.
The latest approval came after the FDA reviewed data from a study with 321 patients, which showed that more than 90% of patients had no complications at the end of the six-month trial.
Cameron is required to conduct a post-market study and follow 1,616 patients for five years to review long-term safety of the defibrillator.
The S-ICD is already on the market in Europe and some other markets.