Are We Complementary or Competitive to Transcatheter?

The answer is yes.

Our device can be viewed as both complementary and directly competitive to the new class of transcatheter valves being developed by Edwards, Medtronic, and others.

It is complementary because it can be implanted in patients that present with a bicuspid shaped valve – a condition strictly contraindicated for transcatheter valve devices.  Even though only 2% of the population is born with a bicuspid shaped valve, over 40% of stenotic aortic valve patients over the age of 70 present with a bicuspid valve!

Our device is also directly competitive because, frankly, it is a better “off pump” solution even for patients presenting with a tricuspid valve.  Unlike transcatheter devices, our device:

  1. Is combined with a surgeon selected “off the shelf” prosthetic heart valve with a proven long term implant history and therefore does not require substantial investment into a new class of heart valve.
  2. Does not require the implantation of a pacemaker – 30% of transcatheter patients do.
  3. Will not inhibit future coronary artery interventions – most transcatheter valves do.
  4. Is safe, relying on minimally invasive “line of site” implant management techniques already fully established by skilled cardiac surgeons.
  5. Is substantially less expensive, positioned to compete in the current healthcare environment.

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