Cardiovascular medical technology firm Biotronik has received approval from the US Food and Drug Administration (FDA) for its implantable cardioverter defibrillator (ICD), which can deliver ultra-high energy on the first shock.
The firms’ Inventra DX is the only system that can provide ultra-high energy on the first shock, offering better protection to patients.
In addition, the company has obtained approval response from the FDA for its Itrevia DX system, a less invasive therapy with an algorithm that can identify successful pain-free therapies for each patient and dynamically re-apply them as needed.
Biotronik president Marlou Janssen said: "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.
"This approval is yet another example of Biotronik’s ability to offer unique stand-alone technology to support electrophysiologists as they pursue their life-saving, life-changing work for patients."
According to the company, the complete Itrevia family, including Itrevia VR-T, Itrevia DR-T, and Itrevia HF-T, were approved together.
The DX System is claimed to be the first defibrillator system equipped to provide dual-chamber diagnostic information with just one specialized defibrillator lead.
It is an alternative to the single chamber devices for physicians, allowing them to solve several potential complications associated with dual chamber devices.