July 21, 2017 — Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica cardiac resynchronization therapy (CRT)-DX implantable cardioverter defibrillator (ICD) systems. The launch of Intica CRT-DX extends the benefits of Biotronik's DX technology to heart failure patients. DX eliminates the need for an atrial lead while still providing physicians with critical diagnostic information based on a true atrial signal.
Biotronik launched DX technology in 2013 with a focus on improving patient care and decreasing the rate of complication. DX minimizes hardware and provides critical diagnostics that allow physicians to better monitor, manage and prevent cardiac events. Intica CRT-DX is the first cardiac rhythm management device for the treatment of heart failure patients that delivers atrial diagnostics without an atrial lead. Atrial diagnostics aid physicians in the early identification of supraventricular tachycardia (SVT), atrial fibrillation (AF) and atrial ventricular synchronization.
"When treating heart failure patients, we are often managing several comorbidities that can increase the likelihood of complications and risk when implanting a CRT-D and in the years that follow," said Larry Chinitz, M.D., a cardiac electrophysiologist in New York City. "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."
Intica CRT-DX also includes Biotronik's recently FDA approved MultiPole Pacing (MPP) technology. MPP enables the left ventricle (LV) to be paced twice per cardiac cycle — sequentially or simultaneously — allowing for even greater customization of heart failure therapy.
Only Biotronik offers MR conditional devices with independent, simultaneous LV paces, according to the company.
The Intica DX device systems also incorporate other technologies including:
- MRI AutoDetect – shortens window of reduced therapy and eliminates the need for post-MRI (magnetic resonance imaging) reprogramming;
- Biotronik Home Monitoring – automatically transmits device data daily; associated with a >50 percent reduction in mortality due to heart failure and a 36 percent reduction in hospitalization for worsening heart failure; and
- Closed Loop Stimulation – equips the device to respond appropriately to physiologic demands and acute mental stress.
For more information: www.biotronik.com