Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Attain Stability quad magnetic resonance imaging-safe left heart leads designed for cardiac resynchronization therapy defibrillators and pacemakers.
The leads feature MRI SureScan technology and are cleared for use with 3 Tesla and 1.5T MRI scans, the Fridley, Minn.-based company said. The leads also feature a side-helix designed to be fixated in veins of various sizes, the company said.
Medtronic said it has initiated a limited European launch, with the 1st commercial implants recently performed at Bergen, Norway’s Haukeland University Hospital.
“This new lead provides another option for left ventricular lead placement that can meet the needs of patients with various anatomies. We now have the ability to place the lead where we want within the vessel,” Svein Faerestrand of Haukeland University Hospital said in a press release.
The company said it initiated a global, prospective, non-randomized, multicenter clinical study looking to examine the safety and effectiveness of the lead in heart failure patients. The study is slated ot enroll 471 patients in the US, Canada, Europe, Hong Kong and Malaysia.
The primary efficacy endpoint will evaluate the nubmer of patients with appropriate pacing capture thresholds in at least 2 programming configurations, and the primary safety endpoint will be lead-related complication-free rate at 6 months.
“LV lead positioning and stability remain a challenge for physicians. Acute and chronic lead dislodgement are still concerns. This lead’s active-fixation mechanism gives us another option to get to the desired pacing location, and stay there,” co-principal investigator Dr. Kevin Jackson of N.C.’s Duke Raleigh Hospital said in prepared remarks.
“We look forward to obtaining results from the Attain Stability Quad clinical study to support approvals in new geographies and reach more patients. Medtronic is committed to helping physicians treat patients with heart failure by pioneering advancements in CRT, and creating therapies that provide more personalized treatment,” Medtronic cardiac resynchronization therapy biz GM and VP Dr. Kweli Thompson said in a prepared statement.
Early last week, Medtronic said it launched a study of dual anti-platelet therapy and its Resolute Onyx drug-eluting stent.
