Fred St Goar, MD, F.A.C.C., is a practicing interventional cardiologist with Advanced Cardiovascular Specialists, a leading cardiovascular care group based at El Camino Hospital in Mountain View. He is also Vice Chairman of the Board at the Fogarty Institute for Innovation, and mentor and advisor for the majority of the organization’s startups.
He attended Harvard Medical School and completed his medical and cardiology training at Stanford. While he was a fellow at Stanford in the early ’90s, Dr. St Goar helped launch several companies, including HeartPort and Cardiovascular Imaging Systems (CVIS).
In 1999, he co-founded Evalve, one of the leading companies in the area of structural heart and valvular intervention, and was the physician inventor of the company’s minimally invasive catheter-based MitraClip system. Evalve was later acquired by Abbott Vascular.
As El Camino Hospital celebrated the 100th MitraClip procedure, we had the privilege of catching up with Dr. St Goar to discuss why he invented the device, its impact on patients and the value of partnering with El Camino Hospital.
Q. How did you come up with the premise for the MitraClip?
A. Up to 10 percent of patients in their mid-seventies suffer from moderate to severe degrees of mitral regurgitation, which is caused by a leaky heart valve. Open-heart surgery used to be the only way to fix this debilitating heart condition, but patients are often too old or sick to survive such an invasive intervention and thus have no therapeutic options.
During my training at Stanford, I was introduced to the medtech entrepreneurial environment and the opportunities it offered for making a big impact. Pioneers like John Simpson, Tom Fogarty, Simon Stertzer and Paul Yock were establishing a tradition of successful cardiovascular innovation, and the significant effect on patient wellness that their contributions were having wasn’t lost on my fellow cardiology trainees and me.
I had a special interest in valvular disease in part due to the technical challenges it posed. In the fall of 1998, I heard of a unique and intriguing surgical approach to repair the mitral valve, the “edge-to-edge repair” where a single stitch was used to fix the leaking valve. I was impressed by the simplicity and elegance of this approach. It struck me that such a simple repair technique should be able to be performed with a catheter, thus using a significantly less invasive approach than open-heart surgery.
I put some ideas on paper and recruited a team of very talented engineers and dedicated professionals, headed by the late, very creative and dynamic Ferolyn Powell. It took us a couple of years of testing to learn that the suture-based approach was not optimal and in fact, was dangerous. On the other hand, a clip system that could be placed on the two leaflets at the location of the regurgitation was not only safer, but significantly more effective and offered a variety of other advantages.
With the newly designed clip device, in June 2003 we traveled to Venezuela where we successfully treated the first patient, a woman in her late 40s. We were fortunate that the procedure was successful, and now 13 years later, this patient is still doing well. This was undoubtedly one of the most memorable days of my professional life, and I am thrilled that the result has been durable.
Q. What were some of the challenges you had to overcome to get the device to market?
A. Getting the MitraClip to market was a marathon process. We had to undergo three sequential, highly complex trials to prove the safety and efficacy of the device. We finally received FDA approval 10 years after treating our first patient. Had we not had the strong commitment, determination and dogged dedication of our team who knew that this device would be of great benefit to patients, the MitraClip would likely have failed to get to market.
Another challenge we faced was convincing physicians and especially the surgical community of the value and benefit of this novel approach. We would often find that “hospital systems” were reluctant to give it a try. This was not true at El Camino Hospital: Thanks to the organization’s open mind and willingness to try new technologies and the patients’ confidence in their physicians, they did a great job of integrating the technology into the hospital’s healthcare portfolio.
On a global perspective, we are also very proud that today the device has been used to successfully treat more than 40,000 patients in 570 hospitals worldwide – that is a lot of patients, patients’ families and patients’ communities who have benefited from this therapy.
Q. What is the significance of the 100th procedure celebration at El Camino Hospital?
A. Back when we were starting companies in the ’90s, there were challenges, but we had many more resources available to support and fund the development of new technologies. There were significantly fewer barriers in terms of both regulatory and reimbursement hurdles. These days, there is less appetite to support these kind of complex, game-changing therapeutic projects as the risks are viewed as high and the returns are unpredictable.
The Fogarty Institute for Innovation, which is housed on the El Camino Hospital campus and supported by the organization, was set up specifically to address these challenges and provide a supportive environment where new, cutting-edge technologies and therapies can be developed.
Thanks to the support and appreciation for innovation that El Camino Hospital and its community provide, we will be seeing a parade of “MitraClip like” projects generated by the Institute. These therapies will have a dramatic impact on the health and wellness of patients locally and globally – something that the hospital will be very proud of.