Biotronik Launches Evia HF-T, World’s First MRI-Approved CRT Pacemaker With Home Monitoring® Capability

In short

German pacing and telemonitoring specialist company Biotronik has excelled itself this time with the announcement of its European market release of the new Evia HF-T pacemaker series. Evia HF-T is the first cardiac resynchronization therapy (CRT-P) device approved for use in an MRI environment.

The Evia HF-T series also offers remote patient management with Biotronik Home Monitoring®, as well as detailed data available via Biotronik’s Heart Failure Monitor. The company claims this information allows for faster therapy intervention to relieve even asymptomatic symptoms earlier and may even help to decrease hospitalisation.

Background

The usage of MR scans increases with age, due to an increased prevalence of comorbidities like stroke, brain tumors and arthritis—conditions that might require MR scans for exact diagnosis. The prevalence of heart failure also increases with age, and given that the average age of patients with heart failure is 75 years, it is a distinct advantage for that heart failure patients to have access to MR scanning.

The Biotronik ProMRI® Evia HF-T series marks the first time a CRT pacemaker has been designed, tested and approved to make MR scans possible. As a result, physicians have the unique opportunity to select the optimal device from the Evia series—offering their patients the most advanced therapy available, plus access to MR scans.

We’ve covered Biotronik’s Home Monitoring® before, but as a reprise, the company is at the forefront when it comes to telemonitoring of heart function. The company’s remote patient management system saw its first clinical application in the year 2000 and uniquely allows continuous, automatic, wireless remote monitoring of patient status and device status with daily updates—all independent of any patient interaction. It’s technology enables unique early detection of changes in patient status and in the so-called COMPAS trial enabled significantly earlier physician interventions.

Clinician comments

“Until now, patients with a CRT pacemaker were denied MR scanning,” remarked Prof. Valeria Calvi MD, Director of Cardiac Pacing and Electrophysiology at University of Catania, Ferrarotto Hospital, Italy. “MR images give essential diagnostic information that impacts important therapeutic decisions and offer clear insights into the progression of the disease. Now that Biotronik enables heart failure patients with the Evia HF-T device to undergo MR scans, it is reassuring that patients can benefit from these optimal diagnostic procedures when they should need them during their lifetime.”

About Home Monitoring® Prof Calvi wrote; “Most heart failure patients suffer from a variety of symptoms which can suddenly escalate and may need immediate attention. Each heart failure patient’s disease management is complex and requires detailed information on his or her disease status and cardiac device system performance. It is vitally important to monitor these patients closely to avoid rehospitalization. For this Biotronik offers advanced solutions with its Heart Failure Monitor and its Biotronik Home Monitoring® system.”

Company comments

“The new Evia HF-T series completes BIOTRONIK’s technologically advanced bradycardia product portfolio. Together with its Lumax 740 tachycardia series BIOTRONIK offers the industry’s broadest portfolio of implantable cardiac devices in brady-, tachy- and CRT-therapy approved for use with MRI,” stated Christoph Böhmer, Managing Director BIOTRONIK. “We have taken a leadership position both in innovation and in offering physicians and their patients the broadest options for individualized therapy, including access to MR scanning,” added Christoph Böhmer.

Source: Biotronik AG