Natick-based medical device maker Boston Scientific Corp. (BSX) has announced the advancement of its Ingenio and Advantio pacemakers in Europe.
The product line has achieved CE Mark approval, which is a manufacturing conformity requirement, and the first European Ingenio implants are being performed in the United Kingdom, Italy and Germany, the company said. The device was first approved in Europe in April.
The pacemakers are for use in patients who need to undergo magnetic resonance imaging (MRI) scans, which is typically restricted to people with the heart devices because of concerns over complications. The BSX devices allow patients to undergo MRIs as needed.
Approved by the U.S. Food and Drug Administration in May, the first U.S. implant of the pacemaker was performed in Cleveland, in May.
“A significant number of patients with pacemakers may be affected by other conditions, which often require MRI scanning,” said Massimo Santini, the doctor performing the surgery in Italy. “The ability for these patients to undergo detection of other conditions is an important advancement in improving overall patient health and outcomes.”
Read more
