ATS Medical (Minneapolis), a maker of cardiac surgery products, said it has completed the final feasibility milestone in the development of its Forcefield technology, a process designed to control the initial interaction between blood and an artificial device, such as a mechanical heart valve prostheses.

"Normally, any device upon insertion into the bloodstream will be recognized as foreign and the body's initial reaction is to send signals that say, 'Hey folks, this isn't supposed to be here'," Michael Dale, president/CEO of ATS, told Medical Device Daily. What happens next is the activation of platelets, which he explained as the "proverbial bouncers at a bar" which inhibit the device, a reaction that often leads to thrombosis, or clotting.

ATS says its 90-day animal feasibility study was completed with positive results regarding the inhibition of platelet adhesion on mechanical heart valve prostheses. But the fact that the technology worked isn't what makes this animal study significant, Dale said, because the company had already proved the efficacy of Forcefield in earlier acute human clinical studies.

"We needed basic evidence of sustainability of this effect," Dale said. "This provides the green light to go forward and plan for human clinical studies."

ATS said its Forcefield technology has been the focus of presentations at the American Society for Artificial Internal Organs (Boca Raton, Florida) conference in June and at the European Association for Cardio-Thoracic Surgeons meeting in September. Previously,

Mark Slaughter, MD, professor and chief of cardiothoracic surgery at the University of Louisville and Jewish Hospital (both Louisville, Kentucky), presented his findings in an acute human trial with "excellent results," according to ATS.

The company said its 90-day animal feasibility study has demonstrated the longer-term sustained effect of Forcefield on a functioning mechanical heart valve implanted in the mitral position. Examination of the surviving animals confirmed essentially zero presence of platelets on the surface of the heart valves after 90 days without the use of anti-coagulation treatment, ATS noted.

"This is a big deal, this has never been demonstrated before with any device or technology," Dale told MDD.

Even more significant is what this technology could potentially mean for future patients who receive an implanted device with Forcefield — the elimination of anti-coagulation therapy. Dale said the company's next step would be to plan for human feasibility trials of the technology.

"Forcefield is an enabling technology insofar as the biocompatible interface that we create between a device and the bloodstream is the result of controlling the manner by which a person's blood first interacts with a device," Dale said. "The result is a natural solution and genuinely biocompatible interface between the device and bloodstream."

He added, "The magnitude of this achievement is one of a kind and we predict will be disruptive in the future to the implantable device marketplace. The elimination of long term anti-coagulation medication would provide physicians greater therapy options in the selection of device type and most importantly better therapy for their patients."

The company's initial product is its Open Pivot Heart Valve, which the company says continues to spur growth in the mechanical valve market segment. Its other offerings include Simulus annuloplasty products for heart valve repair and CryoMaze surgical ablation products.