Biotronik has been granted US Food and Drug Administration (FDA) approval for use of a group of implantable cardioverter defibrillator (ICD) systems with magnetic resonance imaging (MRI) scans.
The systems use Biotronik ProMRI technology, which is designed to allow patients with certain device systems to undergo 1.5 tesla MRI scans without an exclusion zone. This should expand ICD patients’ access to MRI diagnostic scans.
The FDA approval includes the Biotronik Iperia DR-T-with both DF-1 and DF-4 configurations-as well as the Iperia DX system. This ICD hybrid is, according to the company, the only such device which combines the benefits of both single- and dual-chamber devices.
Also included is Inventra ProMRI DX, which, according to a press release, is the only ICD available that offers ultra-high energy (42 joules) on the first shock, for patients with complex heart conditions who may require a higher-powered first shock for effective therapy. The devices are MR conditional when used with appropriate leads to complete the approved ProMRI system.
“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,” says Mark A Marieb, clinical director of Electrophysiology at Yale-New Haven Hospital and Yale School of Medicine in New Haven, USA, and an investigator in the ProMRI Clinical Study.
This FDA approval is the third in the last 18 months for Biotronik ProMRI technology. “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,” says Marlou Janssen, president, Biotronik.
“The ProMRI study and subsequent FDA approvals have been part of a consistent and methodical process for making more MRI options available for US 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 DX device system,” Marlou Janssen adds.
In addition to ProMRI technology, the newly approved devices include other features, such as:
- Closed Loop Stimulation (CLS), Biotronik’s proprietary rate response algorithm, which is designed to allow patients physiologic pacing adaptation, in accordance with their metabolic needs.
- Biotronik Home Monitoring high patient compliance and has demonstrated mortality reduction for patients with heart failure, according to a press release.
- Biotronik ProMRI ICD family is equipped with a battery capacity designed to offer longevity even with energy-consuming processes active.