J&J MedTech Gets FDA Nod for Varipulse PFA System

After the FDA approves Johnson & Johnson MedTech’s Varipulse technology for the management of atrial fibrillation, the company will join the U.S. pulsed field ablation market.
As a result of the agency’s approval of products from Medtronic and Boston Scientific, the industry has seen tremendous expansion this year. To achieve comparable success rates in the treatment of irregular heart rhythm, which might increase a patient’s risk of having a stroke, pulsed-field ablation selectively targets particular cardiac cells while avoiding harm to healthy tissues located in close proximity to the affected area.
Tim Schmid, Chairman of J&J MedTech, informed investors during an October meeting that the company’s $5 billion electrophysiology division had an 11% growth in the third quarter compared to the previous year, with their mapping technology used in over 50% of competitive instances.

J&J said that it created Varipulse to connect smoothly with its proven Carto 3 heart-mapping technology, which gives a three-dimensional model of the structure of the heart as well as live electrical activity. This was done in order to differentiate itself from its competitors.
The firm states that this makes it possible for physicians to perform minimal to zero X-ray fluoroscopy throughout the procedure. Additionally, intracardiac ultrasound instruments make it possible for patients as well as providers to avoid receiving additional amounts of imaging radiation. In addition, the architecture of the device allows for a single transseptal access connection to the inner chambers of the heart, eliminating the need to switch out and interchange catheters.
Earlier this year, Varipulse was awarded a CE mark in Europe as well as a certification in Japan. More than 11 million individuals in Europe, at least 8 million in the United States, and over 1.3 million in Japan are affected by atrial fibrillation (AFib), which is the most prevalent form of cardiac arrhythmia. Additionally, approximately one in four people over the age of 40 are at risk for developing the illness. Varipulse is approved for use in patients with intermittent atrial fibrillation (also known as paroxysmal atrial fibrillation) who have not responded to pharmacological treatments.
In a single-arm clinical research reported earlier this year at the International AF Symposium, it was found that out of 186 patients who were treated, over 75% exhibited no symptoms of atrial fibrillation recurrence after one year. Additionally, there was no evidence of further atrial arrhythmias like tachycardia or flutter.

When just those individuals who had “optimal” ablations were taken into account, the company said that the percentage jumped to 80%. Additionally, the experiment demonstrated that treatments may be finished using fluoroscopy taken for a period of time that was shorter than eight minutes.

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