Boston Scientific (NYSE:BSX) is looking to join rhythm management rivals St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) with its own truly leadless pacemaker, which is being developed to complement its S-ICD line, Dr. Ken Stein told MassDevice.com last week at the annual Heart Rhythm Society meeting in Boston.
Stein said development work on the as-yet-unnamed leadless pacer should be complete next year. It’s being built "from the ground up" for 2-way communication with Boston’s S-ICD devices, he told us.
Although it laid claim to the 1st leadless pacer when it acquired Cameron Health’s S-ICD for up to $1.35 billion in June 2012, that device actually uses leads implanted in a surgically created channel along the patient’s chest. Medtronic’s Micra and St. Jude’s Nanostim devices, in contrast, are designed to be implanted directly in the heart via catheter. The new Boston Scientific device would also use transcatheter delivery, Stein said.
"While on the 1 hand, we see that leadless pacing may be interesting for a small niche of patients who just need single-chamber pacemakers, actually to us the bigger opportunity is pairing it with the S-ICD, so that if you have patients who need defibrillators but who also need pacing, or also need anti-tachycardia pacing, now they’ve got a full, comprehensive option for anti-tachycardia pacing or back up VVI pacing," said Stein, who is chief medical officer for Boston’s cardiac rhythm management division.
"The goal is, in the long run, to just get rid of these endovascular leads," he said.
Stein also said he’s "really thrilled" by the quick FDA approval for the latest iteration in the S-ICD line, the Emblem device, last March. The Emblem model is 19% slimmer and projected to last 40% longer than the original S-ICD.
"To be honest, we got approval ahead of when we had anticipated. People love to complain about the FDA and approval timelines, but I think we’ve also got to give them credit where credit’s due. It’s very nice to see them approving devices like Emblem as quickly as they did. I’ll give a shout-out to the FDA," Stein told us.