Dive Brief:
- Johnson & Johnson said Friday it has struck a deal to buy Atraverse Medical, an atrial fibrillation ablation device developer founded by the team behind Farapulse.
- Atraverse sells a radiofrequency guidewire used to create an atrial septal defect to treat AFib. The Food and Drug Administration cleared the Hotwire device for use in 2024.
- Hotwire competes with products including Boston Scientific’s ProTrack RF Anchor Wire, which Atraverse cited as the predicate product in its 510(k) submission.
Dive Insight:
Atraverse was set up by Steven Mickelsen, Eric Sauter and John Slump. Mickelsen and Slump co-founded Farapulse, the pulsed field ablation company acquired by Boston Scientific in 2021. Sauter was Farapulse’s first employee. The acquired technology established Boston Scientific as a leader in the fast-growing PFA market.
Slump, Mickelsen and Sauter are Atraverse’s CEO, chief translational science officer and chief operating officer, respectively. The company began a limited launch of Hotwire after receiving FDA clearance and raising $12.5 million in 2024. Atraverse expanded commercialization last year after raising $29.4 million.
Nearly 100 cardiac electrophysiologists and interventional cardiologists have used Hotwire in almost 3,000 left-heart access procedures, Atraverse said. Physicians performed 29% of the procedures without fluoroscopy, an X-ray-based imaging technology, and achieved 100% procedural success in a multicenter first-in-human study of nearly 500 patients.
Atraverse told the FDA in its 510(k) filing that Hotwire is mostly identical to Boston Scientific’s ProTrack RF Anchor Wire. Differences included the radiofrequency generator, the availability of a smaller-diameter guidewire and a straight tip configuration, and the sterilization method. Atraverse said none of the differences raised new questions about safety or effectiveness.
J&J named impedance-sensing automatic energy shutoff, compatibility with multiple sheaths and clear tip visibility under intracardiac echocardiography as innovative features of Atraverse’s Hotwire system.
J&J plans to complete the takeover in the second quarter. The company has not disclosed the value of the deal.
Hotwire will slot into a cardiovascular disease portfolio that has driven growth at J&J, with sales at the unit rising 13% to $2.38 billion in the first quarter. Acquired products such as devices from Abiomed and Shockwave Medical have fueled the growth.
