Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ATS Medical has reported that a total of 47 patients have undergone aortic valve replacement with its sutureless ATS 3f Enable Aortic Bioprosthesis at seven investigative sites in Europe within both the feasibility and pivotal clinical trial phases, with eight patients surpassing the two-year implant duration.
Subscribe to our email newsletter
The most recent phase of the clinical trial was designed to evaluate the effectiveness of the ATS 3f Enable Aortic Bioprostheses ‘sutureless’ solution with respect to hemodynamics, avoiding peri-valvular leakage, and valve migration post surgery. The company reported that after more than 25 consecutive procedures within the pivotal trial phase utilizing an updated pivotal trial protocol, the Enable ‘sutureless’ solution has provided excellent clinical outcomes for peri-valvular leak comparable to conventional surgery. It has been further established that valve migration has not been a risk with the Enable heart valve.
The ATS 3f Enable Aortic Bioprosthesis is the second product stemming from the ATS 3f Aortic Bioprosthesis platform. The company will proceed with an expanded clinical evaluation at a select number of international sites as the company proceeds through the regulatory process for US IDE and international CE mark approvals.
Michael Dale, president and CEO of ATS Medical, said: “The potential benefits of a sutureless aortic heart valve are many, but up until the introduction of the Enable heart valve, ‘sutureless’ designs could not claim equality with conventional surgery outcomes.”