AtriCure Makes Significant Progress with Afib Therapy
This study is the first of its kind, evaluating the multi-disciplinary Convergent approach against catheter ablation for patients who suffer from the most serious forms of Afib. We believe that once concluded, this study will be a meaningful step forward in demonstrating the safety and effectiveness of the Convergent approach.â
The CONVERGE studyâs primary efficacy endpoint is for enrolled patients to be Afib, atrial tachycardia, and atrial flutter free, absent class I and III AADs except for a previously failed or intolerant class I or III anti-arrhythmic drugs, with no increase in dosage following the 3-month blanking period through the 12 monthsâ post procedure follow-up visit. The last patient follow-up is expected to be sometime in 3Q19, after which the company will submit final documentation to FDA and seek a PMA.
AtriCure has had a lot of momentum recently. In July the company was listed as one of the 25 most attractive medtech companies on the M&A radar.
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news