LAKE OSWEGO, Ore., July 19, 2017 /PRNewswire/ -- BIOTRONIK today announced 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 proven 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 Dr. Larry Chinitz, 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.
"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," said Marlou Janssen, President of BIOTRONIK, Inc. "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."
The Intica DX device systems also incorporate other industry-leading technologies including:
1 Hindricks, G., Taborsky, M., Glikson, M., Heinrich, U., Schumacher, B., Katz, A., Søgaard, P. (2014). Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): A randomised controlled trial. The Lancet, 583-590.
2 Hindricks G et al. European Heart Journal. 2017, May 10. doi: https://doi.org/10.1093/eurheartj/ehx015
A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris®*, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar®-18, the world's first 4F compatible stent for treating long lesions; Orsiro®**, the ultrathin 60 micron drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.
* Not currently available in the United States.
** CAUTION ? Investigational device. Limited by United States law to investigational use.
These press releases may also interest you