Sutureless Heart Valve Replacement By ATS Medical

December 6th, 2007

Following up on the consolidation of heart valve manufacturers, ATS Medical recently announced Europe-based results for the clinical use of its 3f Enable Aortic Bioprothesis (pictured below).

This is very interesting news as the push to develop the latest-and-greatest minimally invasive procedures seems to be on everyone’s minds (and corporate wallets) as of late.

Personally, I’m incredibly intrigued by the sutureless technology of this tissue valve replacement. (I have a nominal amount of regurgitation around a suture in my aortic valve, following my heart valve replacement. Actually, it’s quite odd reading this report right now. I am just coming back from my annual echocardiogram and visit to my cardiologist just a few hours ago.)

Regardless… Here is the official report from ATS Medical. Also, you should know that in October, 2006, ATS Medical completed a $58 million purchase of 3F Therapeutics, a privately held developer of tissue heart valve products. According to reports, it was this acquisition that opened the door to the $600 million tissue valve market for ATS Medical AND brought the non-invasive surgical technology (3f Enable) to ATS.

Again, this is very exciting times in the heart valve replacement manufacturing community!

ATS Medical Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced that a total of 47 patients have now undergone aortic valve replacement with its sutureless ATS 3f Enable(TM) Aortic Bioprosthesis at seven investigative sites in Europe within both the feasibility and pivotal clinical trial phases. Currently, eight patients have surpassed the two year implant duration.

The ATS 3f Enable Aortic Bioprosthesis is designed to eliminate the traditional suturing required to replace a patient’s diseased aortic heart valve. If suturing can be eliminated from the procedure, surgeons can potentially reduce procedure time and offer less invasive options for the treatment of aortic valve disease. In addition, the elimination of suturing offers the potential to significantly improve valve related hemodynamics by allowing the surgeon to provide a replacement valve of a size larger than what is traditionally possible with conventionally sutured heart valves.

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. 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.

Prof. Thierry P. Carrel of the University Hospital of Bern, Switzerland stated, “We are very encouraged by our ATS 3f Enable heart valve experience. The unique sutureless implantation feature of the ENABLE valve provides several important clinical benefits for our patients. Notably, because the valve requires no sutures to implant we are able to put in a larger valve than would otherwise be possible using a conventionally sutured heart valve. As a result, the hemodynamic performance observed is truly outstanding. And unlike with sutureless percutaneous valves, there has been no trade off or compromise in clinical performance. Specifically, we have not observed any peri-valvular leaks or migration with the ENABLE prosthesis. Prof. Friedrich S. Eckstein, also of the University Hospital of Bern, added, “The ENABLE sutureless implant procedure is remarkably simple. Because we are able to eliminate the suturing and much of the time that normally accompanies aortic valve replacement, we have been able to provide more of our patients a less invasive procedure using smaller incisions without compromising clinical outcome.”

ATS Medical Inc. President and CEO, Michael Dale said, “We are very pleased with the results from our updated pivotal protocol. 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. This was particularly true with regard to peri-valvular leakage. For less invasive aortic valve surgery to move forward as a standard of care, clinical outcomes must be at least equivalent to conventional surgical technique. We believe these results for ENABLE demonstrate this is possible. Our intellectual property in this area is comprehensive and we believe our design is practical and with this milestone we look forward to expanding our enrollment in this exciting clinical trial.”

Here is an interview with Dr. Alan Stewart which addresses the ATS 3f Aortic bioprosthesis — which is made from horse (equine) tissue.

Prof. Sven Martens, MD, PhD, of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany said, “The ATS 3f Enable Aortic Bioprosthesis has been chosen by us because of the excellent hemodynamics, especially in patients with a small aortic annulus. The early results are very promising and while more time is needed, we believe that for these patients, this device may truly advance the standard of care for aortic valve surgery.”

The ATS 3f Enable Aortic Bioprosthesis is the second product stemming from the ATS 3f(R) Aortic Bioprosthesis platform. Utilizing the same valve leaflet design and materials, the company has been able to preserve excellent product performance and durability. ATS has now expanded into the sutureless implant procedure and will utilize these base products and technologies to further advance the standard of heart valve repair and replacement. ATS’ strategy has been to develop and provide an excellent Aortic Bioprosthesis, to utilize this platform to improve standard aortic valve replacement surgery through sutureless products and procedures, and then to provide products and procedures to allow for minimally invasive heart valve repair and replacement in a safe and effective manner. The company will proceed with an expanded clinical evaluation at a select number of international sites as we proceed through the regulatory process for US IDE and International CE Mark approvals.

I hope this helped explain more about ATS Medical and its sutureless heart valve replacement technology.

Keep on tickin,

About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient's Guide To Heart Valve Surgery. This unique book integrates clinical research with the personal experiences of 135 former patients to help future patients and their caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here.