CD&D Executive Editor

Gary Burbach is president, CEO and a board member of Thoratec (Pleasanton, California), the leading developer of ventricular assist devices used for those with severe heart failure.

He came to Thoratec in 2006 and before that he served as president and CEO of Digirad (Poway, California), a provider of cardiology and nuclear medicine imaging products and services, and he continues to serve on that company's board. Before his work at Digirad, he held executive positions at Bacchus Vascular (Santa Clara, California), a developr of treatments for deep vein thrombosis; at Philips Nuclear Medicine, a division of Royal Phillips Electronics (Best, the Netherlands) and before that at McKinsey & Company (Washington/Singapore), a global consulting firm offering services across a range of industrial and functional practices.

CD&D: What were some of the key experiences that brought you to medical technology and the medical device industry?

Burbach: Directly out of business school I worked at McKinsey & Company, consulting with clients in a range of industries. During the last three years at McKinsey I focused on the healthcare industry including providers, payers and medical technology companies. I gravitated towards working in healthcare due to the challenging nature of the assignments as well as the positive impact we were able to have.

It's a significant challenge trying to deliver the best quality care in a cost-effective way.

CD&D: And what about your career path, after that, bringing you to Thoratec?

Burbach: After I left McKinsey, I went on to ADAC Laboratories — a public company that was acquired by Philips Electronics — focused on diagnostic imaging systems, radiation oncology systems, and healthcare information systems. I served as general manager of a few of the businesses and then, after the company was acquired by Philips, the following three years I served as president. I then went on to work for a start-up, Bacchus Vascular, a new venture in interventional cardiology and was there for two years as CEO.

And then most recently, prior to joining Thoratec in 2006, I served as an interim CEO at Digirad, a leader focused on the development of nuclear imaging products and services, where I continue to serve on the board of directors.

CD&D: As president and CEO of Thoratec, you've got to be pleased with the company's development of ventricular assist devices (VADs) and especially the recent big milestone, FDA approval of the company's next-generation Heartmate II VAD. What do you see as the overall impact of the HeartMate II for the company and the heart pump industry in general?

Burbach: I think that in the near term the Heartmate II is a very significant development over the older generation of pulsatile devices.

First of all, it's the first continuous flow pump to receive FDA approval for Bridge to Transplantation and expands the potential uses of VADs in various populations, particularly small patients and women. It's ideally suited for those groups of patients who are underserved by previously approved devices.

Secondly, there are still a significant number of patients who die on the transplant list without receiving a VAD.

It's a big step forward [for the field], an opportunity to further promote the usage of VADs for those on the transplant list who would be benefitted. And it can also lead to a broader view of who might be a transplant candidate.

If you look at the advanced stage heart failure population, it is dramatically under-served by existing therapies. These patients have generally poor outcomes and very poor quality of life, and there is a very small supply of hearts available for transplant. In the U.S. today only about 2,000 of roughly 250,000 Class IV patients receive a transplant.

Additionally, once the device receives FDA approval for destination therapy, we believe about 50,000 to 100,000 patients could be appropriate candidates for HeartMate II VAD therapy, because of its smaller size and greater durability.

CD&D: The number of 50,000 to 100,000 patients may be the ideal pool of patient candidates for this type of device, but that's obviously not the number that you'll be able to reach for actual implant. What do you see as the major barriers, for getting to as many of these patients as possible, and what are your challenges?

Burbach: Initially, certainly, what we look to is referrals, getting cardiologists to refer these patients on to implanting centers. So we will be working on consultation, a sales focus on outreach and education, to build understanding of the therapy, and providing the clinical data so that clinicians can make the right choices.

Typically the cardiologist makes a decision to refer the patient to one of these implanting centers, and the heart failure cardiologists and cardiovascular surgeons at the center then make the decision concerning the implantation of a VAD. The cardiologists and surgeons at the implanting centers have a good understanding of the therapy and what it can do.

But the physicians out in the community who currently manage the large majority of these patients generally have a very limited knowledge of VAD therapy. So we need to assist in educating them.

Another key focus area is to expand the availability of this technology. Today there are only about 100 centers that perform VAD implants, about 40 of them were in the HeartMate II clinical trial.

The first priority is to expand into the 60 current VAD centers which were not in the HeartMate II trial, and we expect to place it in 40 of them before the end of this year.

Subsequently, a longer-term goal is to also expand into many of the nearly one thousand open heart centers which do not currently provide VAD therapy. We believe the combination of current reimbursement levels and the HeartMate II as a more user-friendly technology make this a real possibility in the coming years.

CD&D: What kind of response and feedback have you been getting about the HeartMate II?

Burbach: It's been very, very positive. The clinical community is very excited. Outcomes [following use of the VAD] continue to improve over time in terms of survival, adverse events, functional status, and quality of life. And with newer generations of the technology, we expect to continue to see improved outcomes.

CD&D: Excuse the use of a somewhat over-used expression here, but can we say it's a matter of building the technology and they will come?

Burbach: It's not quite that easy in this case. While building the technology, HeartMate II is a critical ingredient, a milestone we are thrilled to have under our belt.

And there is also a tremendous amount of market development required, particularly in terms of education to change referral patterns of the community physicians who manage these advanced stage heart failure patients.

CD&D: Another obvious issue for medical technology and especially VADs is the regulatory process at the FDA. What would you recommend concerning changes at the agency?

Burbach: Certainly we would like to see the development of a more streamlined approval process for these devices. It's a very extended process. HeartMate II received approval in Europe two-and-one-half years earlier [than FDA approval]. In the U.S. we have this process where approval for use of a VAD for bridge-to-transplant and approval for destination therapy require separate clinical trials. This requires a tremendous amount of expense and time to accomplish, and this is also the case for any subsequent enhancements.

This does limit our ability to rapidly move the therapy forward. If we can find more ways to streamline these processes, this would be beneficial to move the whole field forward.

CD&D: Is there anything else you would like to add or emphasize about the importance of the HeartMate II?

Burbach: Yes, and let me drop back a bit. There's another tangential issue — but very important — concerning education and awareness that is building.

That is the general message, that for these [severe heart failure] patients there is a need for a greater focus on quality of life. That's something most important to this patient population.

When you talk to these patients, their quality of life is very poor. They have limited ability to do the day-to-day things, carry out day-to-day activities, such as walking or shopping. There's just a significant lack of energy.

So it is great talking to patients who have been supported by the HeartMate II. We see them doing these things that weren't possible before. We see clinical outcomes with patients moving from Class IV with dramatic lifestyle limitations to Class I or II where they can resume their normal lives, including their hobbies such as hiking or golfing.

That is clearly one of the most gratifying aspects of what we do at Thoratec.

An example of this is a patient who was recently featured on Good Morning America. She is a young mother who was very sick with a very poor prognosis, but then physicians at Texas Heart (Houston) implanted her with the HeartMate II.

She quickly improved and after a number of months of support with the HeartMate, they found that her heart had recovered and they were able to take her off of the device.

CD&D: Thoratec is clearly the leader in VAD technology, especially with FDA approval of the HeartMate II. But do you see room for other players in this sector?

Burbach: I think that with the limited size of the market today it is difficult to support many implantable VAD companies.

But we expect a dramatic expansion of this market over the coming years. We're in a period of transition, and the next five years is going to be a very exciting period.

So as the market evolves and grows we should be able to support a number of very successful companies.