What We Believe

Recently, I was asked why I thought our aortic valve bypass graft product is competitive compared to transcatheter products that are already in human studies.  After some thought, below are the fundamental reasons why we think we have a good chance for success.

  • We believe a successful aortic valve surgery business should revolve around experienced surgeons safely implanting proven, state of the art heart valves – even if the procedure is done “off pump”.
  • We believe all cardiac surgeons in all operating rooms around the world should be able to confidently provide patients an “off pump” procedure.
  • We believe an “off pump” aortic valve procedure should not be constrained by native valve anatomy, limited to “centers of excellence”, carry a high risk profile, or require an extremely high, perhaps unsustainable, selling price to be profitable.

Are we basing our business on the right fundamentals?  What do you think?

3 Comments

  1. Jay
    Posted November 16, 2009 at 7:57 pm | Permalink

    AVB is a great solution and it is unfortunate that many cardiac surgeons are not using it today. I believe the best aspect of AVB is not having to worry about the risks that TAVI introduces: occlusion of coronary ostia by bulky
    leaflets or low origin, stroke by manipulating the native calcified valve and arch, valve embolization, AR if not a tight fit, aortic rupture by aggressive oversizing, pace maker etc. Further, AVB relying on “off the shelf parts” with a standard valve mitigates the main concern of durability with a compressed transcatheter valve.

    That said, I personally know of an elderly man that had a TAVI with an Edwards valve. The TAVI procedure has had excellent results with no side effects 6 months post-op with significant improvement in QOL in this patient whom had near critical AS, severe AI, NYHA IV etc. An AVB option was explored, however with severe AI, AVB was not considered a viable option by the surgeons consulted. Hence in this instance, TAVI was deemed the only option for this elderly patient with a porcelain aorta
    and poor ileofemoral access.

    There is no doubt that AVB and TAVI will have their place in frail elderly patients that are deemed too high risk for traditional AVR. However, with upcoming transcatheter smaller sheaths and repositional retrievable valves, I believe AVB and TAVI procedures won’t be the first choice when a total percutaneous femoral option exists for patients with good ileofemoral access and valve anatomy. This is similar to the coronary angioplasty versus coronary artery bypass preference by patients today.

    In summary, provided AVB can be safely performed without CPB in a suitable patient, I will predict that AVB will be selected over TAVI in patients with borderline valve anatomy concerns.

  2. Jim Pokorney
    Posted November 17, 2009 at 9:55 am | Permalink

    Thanks for providing your opinion. I appreciate your interest in the field.

    You make good “safety” arguments as to why AVB may be a better alternative for many patients. I believe safety along with “easy adoption” will be two key drivers to our success. As I said in this post, one of our fundamental beliefs is that AVB will be applicability to “all surgeons in all operating rooms anywhere in the world”.

    I also agree – patients with severe AI are not good candidates for AVB. I understand this condition is not present in most AVR patients.

  3. Bob
    Posted November 23, 2009 at 6:13 pm | Permalink

    Re: high selling price
    Article in 22 Nov 09 St. Paul Pioneer Press notes revenue of Edwards – calculated currently at $27,000 +/-. This is unbelievable to me, now retired, but formerly employed by Medtronic and St. Jude Medical in positions with access to cost. Are they trying to recover their start-up costs in 2 years ? Is it any wonder that some congressmen/women want to impose a tax on medical device manufacturers ?

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