dimarts, 20 de novembre del 2018

Abbott launches FlexAbility cath ventricular tachycardia ablation trial

Abbott

Abbott (NYSE:ABT) said yesterday that it launched a study aiming to evaluate ablation treatments for patients with ventricular tachycardia, touting it as the first such trial of its kind.

In the trial, dubbed the Less-VT study, investigators will explore the safety and effectiveness of ablation with the Chicago-area medtech giant’s FlexAbility ablation catheter in treating monomorphic ventricular tachycardia in patients who are unresponsive to drug therapy.

“For some patients with sustained monomorphic ventricular tachycardia, drug therapy is an ineffective treatment option. We want to build a body of clinical evidence that establishes ablation as a therapy solution for people with ischemic and non-ischemic MMVT,” Dr. Paolo Della Bella of Milan, Italy’s San Raffaele Hospital said in a prepared statement.

The trial is already open for enrollment and aims to enroll 600 patients across the U.S. and Europe, and data from the trial will be used to support an FDA submission seeking an expanded indication for Abbott’s ablation therapy tech.

“Data suggests treating people with arrhythmias, including sustained MMVT, reduces the risk of developing other complications and hospitalizations. The goal of the LESS-VT study is to provide physicians with relevant data to help them determine the most effective treatment option for their patients with monomorphic ventricular tachycardia. With recent advances in Abbott’s unique ablation tools and cardiac mapping technology, we aim to uncover treatment strategies to benefit patients so they can return to living healthy, full lives,” Abbott electrophysiology biz medical director Dr. Srijoy Mahapatra said in a press release.

Last week, Abbott said that it won FDA clearance and CE Mark approval in the European Union for its DRG Invisible Trial System intended to allow patients with complex chronic pain conditions to receive a trial treatment with the company’s dorsal root ganglion stimulation system.

The post Abbott launches FlexAbility cath ventricular tachycardia ablation trial appeared first on MassDevice.



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