Innovation in Intervention: Perspectives from Industry

San Francisco, CA—Industry leaders look at the past and present and prognosticate on the future of innovation in interventional cardiology.

Since the beginning of the subspecialty, technological innovations have played a critical role in shaping and defining interventional cardiology as the cutting-edge, transformative field we know today. These developments, resulting from collaborations between the medical community and industry, have brought about substantial advancement in the treatment of patients with CVD, offering less-invasive alternatives and in some cases hope in the fight against disease that would have otherwise been unavailable.  

This year, in celebration of the 25th anniversary of TCT, TCT Daily interviewed industry leaders to get their thoughts on the progress of innovation in interventional cardiology, including Michael J. Coyle, executive vice president and group president of the Cardiac and Vascular Group, Medtronic; Charles A. Simonton, MD, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular; and Kevin Ballinger, global president, Interventional Cardiology at Boston Scientific.

Since the first TCT 25 years ago, what have been the most significant strides in innovation in interventional cardiology? 

Coyle: For most of the last 25 years, TCT has primarily been about the progress of PCI innovations. Over the last 3 to 4 years, however, what’s been interesting is to see the discussion evolve to include other catheter-based therapies, with transcatheter valves being the first to break the PCI monopoly. At this year’s TCT, in fact, we’re going to be introducing the extreme-risk data from the CoreValve trial: so the innovations in transcatheter valves we think are really fundamentally important to treating aortic stenosis in patients who otherwise don’t have any good options.

And secondly, over the past 2 years, renal denervation has become a primary discussion point with interventional cardiologists, especially as it relates to treatment resistant hypertension, which Medtronic has investigated with our Symplicity catheter. We think this patient population could be the single largest set of patients who are currently untreated, since hypertension is the most prevalent of the CVD states.

Simonton: The field of interventional cardiology has rapidly evolved in the past three decades. There have been many device-specific innovations, such as the initial introduction of metallic stents in the 1990s, that have had a tremendous, positive impact on patient outcomes. In addition, the investment in developing clinical evidence to support interventional cardiology treatment decisions continues to increase. Abbott has made significant investments in developing clinical evidence, as demonstrated by our SPIRIT and EXCEL programs supporting the Xience family of DES, Absorb program and MitraClip program, most recently including the initiation of the COAPT trial in the United States. Clinical presentations including Absorb, MitraClip and the Xience family of DES are scheduled to take place at TCT this year.

Ballinger: Twenty-five years ago, our customers were cardiologists responsible for the care of their patients with new and often unproven technologies. Today, however, we see the continuum of care involving purchasing organizations, Joint Commission on Accreditation of Healthcare Organizations’ standards, highly integrated care, numerous patient touch points and an interventional cardiologist who demands cost-effective technologies that improve patient outcomes and quality of life. 

Numerous device solutions have been designed and iterated. DES being the most impactful to date. Industry’s investment in DES continues. In 2005 we recognized many physicians were concerned with dual antiplatelet therapy compliance after DES implantation which led to the Synergy bioabsorbable program. Development of the Synergy stent system would not have been possible without physician partnership and a collective focus on improving patient outcomes.

What current unmet needs in CVD management do you feel innovations in interventional cardiology will have the greatest impact on in the years ahead? 

Coyle: In addition to renal denervation and transcatheter valve technologies, the peripheral business is very focused on drug-eluting balloon (DEB) technologies. Although our initial datasets target superficial femoral artery (SFA) applications, DEB could also have coronary applications, especially with bifurcation stenting. Also, cardiac rhythm management, which has been focused on pacing and ICD therapies, has an application where we are looking at using miniaturized technologies to develop a leadless pacemaker that can be placed into the ventricle with a catheter. So, each of these four areas represents fundamental new growth opportunities for interventional cardiologists and very significant new therapeutic advancements for patients.

Simonton: As the population ages, a growing demand continues to be placed on our health care system. Early interventional approaches that can address unmet needs by providing substantial clinical benefits to patients and economic benefits will have the greatest impact. Some of the areas where there is still significant unmet need include aortic and mitral valve disease, congestive heart failure, atrial fibrillation and treatment-resistant hypertension. Medical therapy alone is not sufficient in many cases and surgical options are not always possible. All of these diseases represent significant, global health challenges and there is potential for innovation in the interventional cardiology field to make a positive impact for patients.  

Ballinger: Industry continues to focus on developing less invasive options for the treatment of CVD by applying our expertise to the entire vascular system, not just the heart. A perfect example is the Vessix renal denervation technology. Recent figures estimate that 1.2 billion people suffer from hypertension, and of those, one in 10 people suffer from medically-resistant hypertension. In an effort to bring a remedy to this patient population, a second-generation renal denervation system engineered with the physician and patient in mind was introduced. The familiar over-the-wire-balloon design of the Vessix technology is enabling a short procedure that helps reduce BP to more normal ranges. 

With 2014 on the horizon, what message would you like to leave interventional cardiologists with as we look ahead to the new year? 

Coyle: When we look back at the last 25 years, almost every technology I’ve brought up — including transcatheter valves, renal denervation and DEB — didn’t exist when TCT first started. Interestingly, over the next 9 months, we’re going to see presentations on definitive CoreValve data in the Extreme Risk Study at TCT; CoreValve data from the High Risk Study and the Symplicity HTN-3 randomized 6-month data on renal denervation sometime this spring; and DEB data for the SFA application by the time we get to mid-calendar year 2014. So we have an exciting array of fundamental trials coming up that will examine how we can impact significant unmet needs using catheter-based therapies.

Simonton: The healthcare industry is changing at a rapid pace, requiring all key stakeholders — physicians, hospitals and manufacturers — to think differently. Stakeholders must consider the value they bring not only to patients, but also to the system. The interventional cardiology industry has been at the forefront of generating clinical evidence to support treatment decisions that maximize patient clinical outcomes. Those outcomes must now be positioned in light of a rapidly evolving environment in which both clinical value and economics are important.

Ballinger: As TCT continually evolves to provide education to support a changing cardiology field, Industry will continue to partner with the interventional community to provide new solutions to address unmet clinical needs and help customers expand and grow their practice. We remain deeply rooted in coronary interventions, but we are excited about our work with physicians to advance new treatment options — not just with better technology, but also with a commitment to therapy development. Together, we look forward to advancing cardiology.