Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US.
The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity in the atrium, as the system itself provides the necessary atrial signal information.
Atrial diagnostics are used for the early detection of supraventricular tachycardia, atrial fibrillation and atrial ventricular synchronization.
“When treating heart failure patients, we are often managing several co-morbidities that can increase the likelihood of complications and risk when implanting a CRT-D and in the years that follow. Balancing risk and therapeutic needs has historically been a challenge. CRT-DX changes this and creates a higher echelon of patient care. Now there is an ICD for heart failure patients that minimizes hardware and risk while providing optimal diagnostics to help patients feel better and stay out of the hospital. The addition of DX technology to a CRT device is a breakthrough,” cardiac electrophysiologist Dr. Larry Chinitz said in a press release.
The newly cleared device also offers the company’s MultiPole Pacing technology to allow the left ventricle to be paced twice per cardiac cycle for more heart failure therapy customization options, as well as MRI AutoDetect, which manages the device safely during magnetic resonance imaging scans.
“Biotronik is disrupting the status quo and setting a new standard of care as we continue to introduce innovations that help hospitals improve outcomes, lower readmissions and take patient care to a new level. Our DX technology is standalone in an industry that knows the rate of complication increases with more leads. Doctors trust and rely on our DX technology because it delivers—less hardware, less complications, paramount diagnostics. We know that the impact of DX is profound for patients and that is why we invested in bringing Intica CRT-DX to market,” Biotronik prez Marlou Janssen said in a prepared statement.
Earlier this month, Biotronik released results from the Bioflex-I pivotal clinical trial of its Pulsar-18 self-expanding stent designed for treating patients with peripheral artery disease, touting high rates of freedom from major adverse events and primary patency.