Biotronik said today it won FDA premarket approval for its Iperia ProMRI HF-T cardiac resynchronization defibrillator, which is designed to be compatible with diagnostic magnetic resonance imaging scans.
The Iperia line of devices also features remote monitoring with daily automatic transmission and closed loop stimulation designed to adapt heart rate in response to physiological demands, Biotronik said.
“Heart failure patients are often struggling with other health conditions that require medical intervention. These patients need effective and efficient treatment. Access to MRI scans is a critical step to ensuring quality patient care extends beyond device implantation. This must become the standard of care,” Dr. Theofanie Mela of the Massachusetts General Hospital said in a press release.
Biotronik’s MR conditional tachycardia devices are designed to be compatible with 1.5 tesla scans without an exclusion zone, the company said.
“The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care. Biotronik now offers a comprehensive portfolio of MR conditional ICDs. We’re driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patients’ lives,” Biotronik prez Marlou Janssen said in a prepared statement.
Last month, Biotronik released long-term data from registry studies of its Linox and Linoxsmart implantable cardioverter defibrillator leads, touting the survival probabilities of over 95% at 4 and 5 years.
The company said its Galaxy and Celestial registry studies include data from a total of 3,933 Linox ICD leads implanted in 3,840 patients across 146 U.S. study centers.
Data from the 2 studies indicates a survival probability of 96.3% with the Linox leads at 5 years and a 96.6% survival rate at 4 years with its Linoxsmart leads. Data from the studies was published in the Journal of Cardiovascular Electrophysiology.