Biotronik has announced that it will solely supply the proprietary DX models for new single-chamber implantable cardioverter-defibrillators (ICDs) implants moving forward.
The move is being made in response to overwhelming recent clinical data demonstrating superior diagnostics and decreased complication risk of DX compared to traditional high-voltage systems, the company says in a press release.
“Based on the current evidence, it is clear we must focus on what is proving to be a lower risk technology with added benefits,” said Alexander Uhl, Biotronik CEO. “Therefore, we have made the decision to offer only DX technology for new patients needing a single-chamber ICD, providing equivalent therapies along with additional atrial monitoring data, as recommended by current guidelines.”
The guidelines for atrial fibrillation (AF) from the American Heart Association (AHA) in 2019 and the European Society of Cardiologists (ESC) in 2020 recommend continued monitoring and evaluation for patients with atrial high-rate episodes (AHRE), with the ESC noting a preference for remote monitoring.
“We are very proud that our DX technology provides the only lead available on the market offering both ventricular pacing/defibrillation and atrial monitoring,” said Ryan Walters, Biotronik US President. “Due to DX´s ability to provide additional patient and clinical benefits, it became clear to us that we should be using DX technology with every Biotronik single-chamber ICD.”
Paired with Biotronik’s home monitoring, DX allows a physician to identify, assess and monitor a patient’s AF burden and subsequent disease progression over time.
DX has shown superior AHRE detection compared to single-chamber ICDs, equivalent AHRE detection compared to dual-chamber ICDs, and in the recently published MATRIX study, a 99.7% positive predictive value of AHRE detection in episodes greater than one hour.
“The MATRIX study is the most recent and largest DX study, adding to the expansive evidence base supporting DX superiority over the ten years of DX being offered in the market,” said David Hayes, chief medical officer. “”There’s simply no reason to implant a traditional single-chamber ICD when the DX system provides the same standard of care with the additional guideline-recommended atrial monitoring benefits.”
