ATS Medical (Minneapolis) had hoped that its artificial heart valve technology would someday have potential for use in less invasive port access and robot assisted procedures but the company never planned on pursuing the opportunity with its current valve.
That was until some of the company's surgeon customers recognized the potential for just such a procedure. Earlier this week ATS reported the first human robot assisted endoscopic aortic valve replacement using the daVinci Surgical System from Intuitive Surgical (Sunnyvale, California) to implant the ATS 3f Aortic Bioprosthesis. Allen Raczkowski, MD, performed the procedure at Banner Baywood Health Hospital (Phoenix).
Michael Dale, president/CEO of ATS Medical, told Medical Device Daily that the efforts to date to develop a less invasive, robot-assisted procedure to implant the 3f valve have been primarily surgeon-driven. The surgeons "got ahead of us" and realized that such a procedure might be possible using the valve that the company recently introduced into the U.S. marketplace, he said.
"Most of our work has been focused further down the road on our suture-less valves in these procedures ... we did not contemplate that the first generation valve" had that potential, Dale said.
The FDA approved the 3f valve about a year ago (Medical Device Daily, Oct. 31, 2008).
The company is developing a suture-less deployment option for the 3f valve, Dale said, explaining that it is the same valve mounted on self-expanding nitinol frames that eliminate the need for suturing at all. "Those, by design, are intended to facilitate less invasive procedures in the future," he said. "In the United States it was not originally anticipated that the conventional valves could be done through such small holes."
Because the ATS 3f valve is the first truly stentless valve in the world, it has no rigid supporting stent, the company said. As a result, the valve is completely pliable which allows it to be folded into a small diameter and introduced to the body through small ports using minimally invasive techniques. According to ATS, no other commercially available valve can be manipulated in this manner.
"The ATS 3f Aortic Bioprosthesis is the only valve that has the extreme flexibility necessary for small access robotic ports and it provides excellent hemodynamic characteristics which are important for the patient's quality of life," Raczkowski said.
The fact that a minimally invasive aortic valve procedure is possible is "potentially good news for a number of folks," Dale said, mentioning first and foremost the patients, and then of course ATS.
For the company, it means that the potential market opportunity for the ATS 3f valve may be broader than the company originally planned, Dale said.
"We intend to work hand-in-glove with various robotic centers" to determine what additional tools may be required to do these robot-assisted procedures, Dale said. While the valve itself does not need to change, he noted that the procedure may require additional tools and said that if so, ATS will make them.
For patients, the benefits of a less invasive aortic valve procedure are obvious.
"For any procedure people desire a less-invasive outcome for cosmetic reasons as well as other [clinical] reasons," Dale said. The challenge, he added, is making the procedure less invasive without compromising clinical outcome.
ATS said this procedure establishes the expansion of its minimally invasive initiatives to the 3f product line in addition to the ongoing efforts with the ATS CryoMaze surgical system and the ATS Simulus family of annuloplasty products. The company said it has also created the position of business development manager of minimally invasive procedures to focus increased resources on the development of procedures and products to drive adoption, expand markets, and provide less traumatic surgical options for patients.
"ATS Medical has been committed from the beginning to the development of minimally invasive solutions for the treatment of structural heart disease. The ability to remove and replace a diseased heart valve in a minimally invasive manner represents a dramatic benefit for patients for two reasons: better clinical outcomes by removing the diseased valve as opposed to leaving it in place, and secondly, a much more cosmetically favorable procedure versus the pain and scaring associated with conventional open chest surgery," Dale said. "This landmark robot assisted endoscopic aortic replacement procedure by Dr. Raczkowski is another important step toward providing surgeons and patients better options for the treatment of structural heart disease without an open sternotomy."
Amanda Pedersen; 229-471-4212