Johnson & Johnson (J&J) MedTech has announced the launch of the Varipulse platform—a system used to perform catheter ablation procedures for the treatment of atrial fibrillation (AF)—in the Asia-Pacific region.
“PFA [pulsed field ablation], as a new type of energy, has the potential to further enhance the safety and efficacy of catheter ablation treatment, which is desirable for patients,” said Yasuo Okumura (Itabashi Hospital, Tokyo, Japan). “PFA is a relatively new medical technology and, therefore, it is important to continue to assess its effectiveness and efficacy in Asia while ensuring proper use. But, so far, we know that the integration of PFA technology with 3D mapping enables physicians to review their procedure in detail, and this contributes to quality of healthcare for patients.”
J&J MedTech claims that its Varipulse platform is the first PFA technology designed to streamline ablation and mapping through a single integrated workflow with the Carto 3 system. This 3D electroanatomical cardiac mapping technology enables real-time visualisation and supports precision, efficiency, reproducibility, and procedural accuracy, for physicians treating AF patients, according to the company. It enables safe and efficient, patient-centric therapy with minimal-to-no fluoroscopy exposure, and is compatible with deep and/or conscious sedation, J&J MedTech also states.
A press release from the company goes on to detail that this innovation is backed by clinical evidence from the inspIRE and admIRE clinical trials, both of which have demonstrated strong safety and effectiveness with the Varipulse platform.
In inspIRE, 80% of patients achieved freedom from recurrence, with zero primary adverse events. In admIRE, results showed a 75% overall primary effectiveness success rate and a 2.9% primary adverse event rate; 100% of patients achieved acute procedural success with 43% having same-day discharge; and 25% of procedures were performed without fluoroscopy.
Additionally, in the ongoing VARIPURE registry—which included first-time users—there were no serious adverse events and no complications linked to the platform, including zero neurovascular events or coronary spasms, J&J MedTech relays.
“The introduction of the Varipulse platform in the Asia-Pacific region marks a significant advancement towards our goal of transforming atrial fibrillation care,” stated Jing Li, vice president of electrophysiology and neurovascular for the Asia-Pacific region at J&J MedTech. “The adoption of the Varipulse platform could demonstrate the unique value of integration with Carto 3D to enhance efficiencies in the workflow of AF treatment and improve patient outcomes.”
