FDANews
FDAnews Device Daily Bulletin

Medtronic Gets CE Mark for CRT Leads

Aug. 24, 2017

Medtronic has received CE Mark approval for its Attain Stability quad cardiac resynchronization therapy leads.

The leads are MRI safe and designed for CRT defibrillators and pacemakers. They are cleared for use with 1.5T and three Tesla scans. They include a side-helix that can be affixed in veins of several sizes.

Medtronic has begun a limited European launch, with the first commercial implants performed at the Haukeland University Hospital in Bergen, Norway. The company has launched a global clinical study to determine the lead’s safety and effectiveness in heart failure patients.

View today's stories