Biotronik said today it won FDA premarket approval for its latest family of MRI compatible implantable cardioverter defibrillators and won another premarket approval for its Astron peripheral self-expanding stent system.
The company’s ProMRI ICD portfolio approval includes the DF-1 and DF4 configured Iperia DR-T, the Iperia Dx hybrid ICD and the Inventra ProMRI Dx which offers 42 joule 1st shocks for patients with conditions requiring higher-powered 1st shocks, the company said.
“We have truly entered a new era of total health care for cardiac rhythm management patients who rely on ICDs to monitor their hearts and provide life-saving therapy when demanded. Devices that are tested to be safe and approved by the FDA for use in MRI scans provide assurance to patients and all of their current and future healthcare providers that this therapy will not create a compromise for other diagnostic needs in the patients’ lifetimes,” study investigator Dr. Mark Marieb of the Yale School of Medicine said in a press release.
The approval is the 3rd in the last 18 months for Biotronik’s ProMRI devices, the company said.
“Our goal is to integrate ProMRI technology across our entire line of implantable systems, and in doing so, provide access to MRI diagnostic scans for all CRM patients. The ProMRI Study and subsequent FDA approvals have been part of a consistent and methodical process for making more MRI options available for U.S. cardiac device patients, starting with single- and dual-chamber pacemakers with an exclusion zone in May 2014, then full-body for the same pacemaker lines in March 2015, and now ICDs for full-body scans, including Biotronik’s unique DX device system. This is meaningful technology that will enhance the quality of healthcare for patients throughout their lives,” prez Marlou Janssen said in a prepared statement.
Biotronik’s Astron peripheral self-expanding stent system is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessels with diameters between 4.3mm and 9.5mm, and lesion lengths up to 105mm, the company said.
Biotronik did not offer any specific plans for commercialization or launch of its Astron stent.