FDA Approves MR Conditional Tachycardia Devices from Biotronik

Biotronik announced Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation (CLS) that adapts the heart rate in response to physiological demands.

Iperia HF-T was developed with BIOTRONIK’s ProMRI, Home Monitoring, and CLS technology, creating an advanced cardiac resynchronization therapy defibrillator (CRT-D) designed to support each patient’s unique healthcare journey. BIOTRONIK’s MR conditional tachycardia devices ensure patients have access to 1.5T scans without an exclusion zone. Home Monitoring provides automatic daily transmission of data relating to arrhythmic events and heart failure statistics, which have been shown to reduce all-cause mortality by more than 50 percent. For heart failure patients, early detection of deterioration reduces patient mortality.

“The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care,” said Marlou Janssen, President, BIOTRONIK, Inc. “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.”

A press release can be found by following this link.

Direct Flow Medical Launches Transcatheter Aortic Valve System in Europe

Direct Flow Medical announced European commercial market launch of the DirecTrack™ Delivery System, a next generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.

The Direct Flow Medical transcatheter aortic valve system, with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.

The next generation DirecTrack Delivery System features advanced ergonomic design and functionality to provide physicians with greater procedural control during valve implantation. “I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery” stated Joachim Schofer, M.D., Professor of Cardiology, Hamburg University Cardiovascular Center, Hamburg. He continued, “I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome.”

“We’re pleased to provide physicians with this latest advance in TAVI procedural control” stated Dan Lemaitre, President and CEO, Direct Flow Medical. He said, “The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome.”

A press release can be found from Direct Flow Medical website by clicking here.