St Jude’s Nanostim leadless pacemaker study exhibits long-term clinical benefits

8 May 2016 (Last Updated May 8th, 2016 18:30)

US-based medical device company St Jude Medical released new data from its Leadless II IDE study, which exhibits long-term safety of retrievability of the Nanostim leadless pacemaker.

Nanostim

US-based medical device company St Jude Medical released new data from its Leadless II IDE study, which exhibits long-term safety of retrievability of the Nanostim leadless pacemaker.

Presentations also demonstrated the pacemaker's ability to reduce acute and mid-term complications.

Studies were conducted across Europe where the Nanostim leadless pacemaker were retrieved in 14 patients up to 3.2 years post-implantation without any serious adverse events.

Mount Sinai Hospital electrophysiology director and LEADLESS II study primary investigator Dr Vivek Reddy said: "Device retrieval is a desirable feature of implanted leadless pacemakers because it offers physicians options in the future so that we can provide optimal care for our patients.

"We have now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability, even up to three years, is possible with the Nanostim leadless pacemaker."

In a new analysis from Leadless II study data and real-world claims data from the Truven Health MarketScan database, which tracks US healthcare claims and Medicare supplemental insurance encounters, an international group of researchers revealed that the Nanostim leadless pacemaker resulted in fewer complications in both the first month post-implant as well as in the first two years post-implant.

"It has achieved all of its clinical endpoints and was completed on time."

The data also exhibited benefits over time, with patients receiving a leadless pacemaker, enabling better combat of infections and lead-related adverse events.

The Nanostim pacemaker is a small, implantable device which triggers electrical pulses to the heart to treat bradycardia, a condition where the heart rate is too slow.

The devices map the heart issues electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements.

It is implanted via the femoral vein with an 18 F introducer, the smallest available for a leadless pacemaker in a minimally option for pacemaker delivery, potentially reducing overall complications including device-related infection of the pocket and lead failure.

More than 1,100 Nanostim leadless pacemakers have been implanted globally and it is currently undergoing a clinical study to secure the US food and drug administration (FDA) clearance.


Image: St Jude Medical Nanostim leadless pacemaker design. Photo: courtesy of Business Wire.