After enduring a recall and threats of Justice Department and SEC investigations, Boston Scientific (NYSE:BSX) has gotten some good news from the FDA, which has removed the remaining holds on defibrillators made by the company.
In an SEC filing, the company says the FDA cleared manufacturing changes to its Livian, Renewal CRT-Ds, as well as the Confient, Prizm and Vitality ICDs. "We have now resumed U.S. distribution of all our CRT-Ds and ICDs, and you may implant all these devices. Your local sales representative will work with your hospital to replenish inventory," the company says in a letter to doctors. "Throughout this process there has been no indication of any risk to patient safety. We do not recommend any modifications to normal follow-up procedure for patients previously implanted with Boston Scientific CRT-Ds or ICDs."
Boston Scientific recalled its ICDs in March after discovering it hadn't received FDA approval for manufacturing changes. The FDA allowed the company to resume sales of its Cognis CRT-Ds and Teligen ICDs April 15. But the remaining five products represent an older generation that account for less than 10 percent of the division's sales, says JPMorgan analyst Mike Weinstein, as quoted by the Boston Globe.
At least one analyst has said the move should result in roughly $470 million in lost sales over the next two years, the Boston Business Journal notes.
- read the letter to doctors
- get more from Mass Device
- check out the Boston Business Journal's coverage
- see the Boston Globe's report
ALSO: Boston Scientific is teaming with Philips Healthcare and Siemens Medical Solutions to provide doctors with a tool that can give a 360-degree view of the heart. Report