FDA regulators today approved a 1st-of-its-kind implantable heart monitor, CardioMEMS’ Champion HF technology for remote patient monitoring, spurring St. Jude Medical (NYSE:STJ) to exercise its option to acquire the company.
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.
St. Jude already owns 19% of the company with an option to buy, which the company said today that it intends to exercise. The medtech titan paid $60 million for its stake in 2010 and shook hands on a $375 million price tag for the remaining 81%. The deal is slated for close in the 2nd quarter of 2014.
"Unlike tele-monitoring of weight and blood pressure, transthoracic impedance or intensified clinic follow-up, the CardioMEMS HF System is the only FDA-approved monitoring technology that has demonstrated the ability to significantly reduce heart failure hospitalizations in a large-scale clinical trial," St. Jude group president Dr. Eric Fain said in prepared remarks. "This one-time implant, delivered using a catheter-based procedure, will allow physicians to proactively manage pressures to an individually tailored target rather than reacting to symptoms once a patient’s heart failure has worsened
The Champion HF implant is the 1st of its kind to provide pulmonary artery measurements, allowing a physician to remotely monitor a patient’s condition and intervene if necessary. The device may help keep patients out of hospitals through remote care and early intervention, regulators said.
"Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older," according to FDA Center for Devices & Radiological Health director Christy Foreman. "The goal of this 1st-of-its-kind implantable wireless device with remote monitoring of pulmonary artery pressure is to reduce heart failure-related hospitalizations."
The 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 win is a major boost 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 Champion HF device.
CardioMEMS seems to have hit on good timing for its remote monitoring win, coming just a couple weeks after remote monitoring technologies made a big splash at Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco.
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, but the technology was substantially different from the Champion HF system.
The Champion HF implant’s primary rival is Reveal LINQ insertable cardiac monitor from St. Jude arch-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 earlier this month.
Updated May 28, 2014, at 1:15 p.m. with more details about the FDA win and St. Jude Medical’s acquisition.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.