Cath Lab Digest

This month we continue on the lower limb treatment strategies. I have been impressed with the flourishment of conferences and the ability to see cases performed at the highest levels throughout the world. I just returned from the LINC meetings and saw some amazing treatments for patients with PVD. What I was most struck by was the fact that in a large proportion of the cases, the devices seen are not available in the U.S. How is this possible? With little exception, most if not all devices were iterated in the United States with U.S. companies. Why is this?

Well for the most part the FDA has mandated that all companies with novel devices have to prove the device safe and effective. This process seems simple but in many cases becomes daunting. In Europe the process is much simpler which translates in industry as cheaper. Clearly, the benefit is the opportunity and exposure to many different devices that have multiple competitors in some cases to drive costs down. Why is this difficult in the U.S.?

A perfect example is the drug-coated balloon for SFA treatment. Currently in the Europe, there are no less than 5 current technologies that have been available for over 2 years. We in the U.S. are currently on our first trial that from Wall Street estimates are costing a fortune. These costs for any small start-up are prohibitive for any company but more so for small companies. Therein lies one reason the companies have interest in moving this research abroad. This is why the device industry has changed the premise that the U.S. leads in medical technology. We lead in innovation but Europe now leads in device usage and we lag behind and in some cases far behind. Current estimates place a drug-coated balloon technology to become available in the U.S. at 2014—fully 5 years after Europe. I do not believe this is only the fault of the FDA. They are truly committed to safety and must, to their best ability, ascertain the risks and benefits for any device or medication prior to its general use.

I am encouraged from the VIVA meeting this year where the FDA has signaled an interest in having a first in man (FIM) study within the U.S. This may be important to hear but more important to see. I cannot believe that we either through the need for safety or the lack of a predicate device cannot come to some path that allows for the safe implementation of a device with all the constraints of medical science to allow the benefit to be passed to our patients.

I do not believe I am alone here but welcome your thoughts.

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Dr. Garcia received his B.A. and M.D. degrees from the University of Arizona. He was an intern and resident at Parkland Memorial Hospital, University of Texas at Southwestern in Dallas, Texas. He received his training in cardiology at the University of Iowa Hospitals and Clinics in Iowa City, Iowa, and as an interventional cardiologist at the Beth Israel Deaconess Medical Center, Harvard Medical School. Further, he received his peripheral vascular training at St. Elizabeth’s Medical Center, Tuft’s University, Boston, Massachusetts. He then served as the Chief of Vascular Medicine and Peripheral Vascular Interventions for the Florida Heart Group in Orlando, Florida. Dr. Garcia returned to Harvard’s Beth Israel Hospital as a full-time interventional cardiologist and Director of the Peripheral Cardiovascular Program and Peripheral Interventions at the Beth Israel Deaconess Medical Center as well as the Director of the Interventional Fellowship Program. This program developed into one of the busiest in the city of Boston, performing over 600 peripheral procedures per year.

Dr. Garcia has now returned to St. Elizabeth’s Medical Center as Chief of the Section of Interventional Cardiology and as Associate Director of the Vascular Medicine Program. Dr. Garcia’s work has largely focused on arterial occlusion-reperfusion models and the efficacy of therapeutic modalities or interventions with regard to free radical generation or endovascular stenting outcomes. Dr. Garcia continues his research interests in a wide variety of studies including acute MI studies, unstable angina studies, interventional trials, peripheral interventional trials, angiogenesis trials, imaging modality studies, and numerous device trials for both the coronary and peripheral circulations. His work has been presented in numerous manuscripts, abstracts, textbooks and textbook chapters.