Inliven CRT-P device gets CE mark to treat heart failure

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Boston Scientific has received CE mark approval for its Inliven cardiac resynchronisation pacemakers (CRT-P) for the treatment of heart failure. According to a company release, the new device is the first CRT-P that relies on a physiological parameter, respiration, to allow the pacemaker to follow the patient’s breath and help create an appropriate pacing rate.

Following the CE mark approval, the first implants of the Inliven device took place at the Elisabethinen Linz Hospital in Linz, Austria, performed by Thomas Schwierz, in collaboration with Siegmund Winter, resident cardiologist at the same hospital.

“The Inliven is the first CRT-P that relies on the patient’s own respiratory signal to help provide the patient with rate-adaptive cardiac resynchronisation pacing,” said Winter. “By detecting the patient’s own minute ventilation, the device can determine the rate of pacing that can best help the heart failure patient. This is most important particularly during exercise, which is recommended in the guidelines for these patients. Regardless of which type of exercise is attempted, the RightRate technology helps support the exercise that these patients need.”

In addition to the RightRate minute ventilation technology, Inliven also provides APScan, for helping physicians identify patients at risk for severe sleep apnea. Sleep apnea is one of the most common comorbidities in patients with cardiovascular disease with 60% prevalence, and up to 80% of these patients remain undiagnosed. It is linked to increased risk for co-morbidities such as atrial fibrillation, heart failure morbidity and mortality, and sudden cardiac death.

“Pacing technologies have evolved over the years to more closely respond to the patient’s own signals,” said Michael Onuschek, senior vice president and president of Europe, Middle East, and Africa at Boston Scientific. “The launch of INLIVEN represents a key milestone in the development of our pacemaker portfolio, helping physicians to better manage heart failure and related comorbidities.”

The Inliven CRT-P is compatible with the Latitude NXT Remote Patient Management System, which would enable physicians to conduct remote follow-ups of these device patients to monitor specific pacemaker information and comorbidity status.