St. Jude Medical (NYSE:STJ) wasted no time in closing its acquisition of CardioMEMS, days after the FDA approved the Champion HF implantable heart monitor, saying it plans to begin a "strategic" launch of the device in the U.S.
"St. Jude Medical’s acquisition of CardioMEMS shows our commitment to providing innovative medical device solutions that reduce the burden of complex diseases like heart failure, both on patients and health care systems. The CardioMEMS HF System achieves this goal by setting a new treatment paradigm for heart failure that reduces hospitalizations and improves the quality of life for patients," chairman, president & CEO Daniel Starks said in prepared remarks.
St. Jude said it closed the acquisition May 30, 2 days after the FDA approved the CardioMEMS device, adding a $375 million payout to the $60 million it had already spent to acquire a 19% stake in CardioMEMS in 2010.
The Champion HF system is comprised of a battery-free implant that sits permanently in the pulmonary artery, a catheter-based delivery system and a home communicator that acquires and processes signals from the device and routes data to healthcare providers. The device won indication for monitoring heart and pulmonary artery pressure rates in patients with Class III heart failure who have in the past year been hospitalized for heart failure, according to an FDA memo.
The FDA approval was based in part on CardioMEMS’ 550-patient clinical trial, which found that at 6 months 98.6% of patients had no device-related safety issues and that 100% of the implants were operational. There were no explants or re-implants during that time, according to the FDA. The PMA was a major win for CardioMEMS, following some uncertainty after last year’s FDA advisory panel meeting and a 2011 rejection.
The FDA panel issued a mixed vote on the Champion HF system in October 2013, ruling that the device was safe but that existing studies failed to demonstrate that it was effective. A similar panel vote in 2011 had resulted in CardioMEMS receiving a non-approvable letter in 2012 for the device.
Remote monitoring technologies made a big splash at the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco last month. Researchers there announced that remotely monitored pacemaker patients saw a significant survival boost over patients not receiving remote monitoring, and higher engagement seemed to translate to lower mortality. The mega-study marked an important milestone for remote monitoring technology, with researchers reporting positive data from more than 260,000 patients across the U.S. who were implanted with St. Jude’s pacemakers, although the technology was substantially different from the Champion HF system.
The Champion HF implant’s primary rival in the implantable heart monitor game is the Reveal LINQ insertable cardiac monitor from St. Jude’s cross-town rival Medtronic (NYSE:MDT). The Reveal LINQ device is smaller than an AAA battery and is implanted just beneath the skin of the chest, capturing and transmitting heart rhythms via the company’s CareLink remote monitoring portal. Medtronic won U.S. and European clearances for the Reveal LINQ system earlier this year and Canadian approval in May.
