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BIOTRONIK gets FDA nod for a first of its kind implantable cardioverter defibrillator

by Gus Iversen, Editor in Chief | April 20, 2015
BIOTRONIK, a leading manufacturer of cardiovascular medical technology, has announced the FDA approval of the only implantable cardioverter defibrillator (ICD) that can deliver ultra-high, 42 joules, energy on the first shock. The approved device, Inventra DX, coincided with the simultaneous approval of the Intrevia DX family of ICDs — which utilizes an algorithm that can identify successful pain-free therapies for each patient and dynamically re-apply them as needed.

The DX line of systems is unique in that they utilize a single coil lead for dual chamber diagnostics, which BIOTRONIX says can reduce complications. In some cases, a patient with high defibrillation thresholds requires greater shock treatment, and the Inventra system is designed to meet those needs.

“Physician experts in the field of electrophysiology have indicated that meaningful therapeutic innovations available in Itrevia and Inventra ICDs - like high energy options, DX systems and CLS - make it easier for physicians to tailor therapy and improve the quality of life for their patients," said Marlou Janssen, president of BIOTRIK.

DX technology is based on more than a decade of engineering refinement to ensure accurate and reliable sensing and processing of the atrial signal. Due to its unique technology, the DX System has continued to drive BIOTRONIK’s U.S. customer adoption since it was initially introduced in February 2013.

The DX System provides dual-chamber diagnostic capabilities with a single lead, which reduces risks associated with additional hardware for patients while providing valuable clinical information to the physician. The system utilizes the Linoxsmart S DX lead with floating dipole, based on proven technology, with a state-of-the-art ICD DX device – which has sophisticated atrial signal processing capabilities to provide dependable and consistent atrial signal to detect silent atrial fibrillation. SMART Detection® algorithm and MorphMatch can discriminate atrial tachyarrythmias to help reduce the risk of inappropriate shocks.

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