Heading into ACC.15, Medtronic's Mike Coyle, executive vice president, cardiac and vascular group, talked about what Medtronic the industry and Medtronic's focus at the conference.
CVB: What trends do you see in the cardiovascular care field?
Coyle: One of the of biggest changes we’re seeing right now is how cardiovascular service line administrators are redefining the "value" of a product, solution or technology. Previously, "value" had always been focused on its acute clinical performance. Now, though, as chronic disease continues to burden our nation’s healthcare system, "value" is being viewed from a long-term clinical perspective and across the continuum of care. The term is also incorporating a financial component, meaning that a technology or solution must have a net positive financial impact, improve provider efficiencies, or increase patient access to care to be considered of significant value to cardiovascular team. Through embracing these changes, we’re focusing on how we can better partner with cardiology departments to maximize the value they receive from our products, technologies and solutions.
Another trend we’re seeing is in the development of radically smaller devices and biological sensors. At Medtronic, an integrated team of engineers from different perspectives, and with a variety of capabilities, came together several years ago to redefine product engineering and manufacturing of our devices. They didn’t want to make devices just a little bit smaller; they wanted to radically reduce device sizes by 90 percent through the development of “deep miniaturization” technology. What has developed is not only a new way of thinking, but a new way of working within the medical device industry – engineers in technology development, product development, manufacturing and quality analysis began working hand-in-hand, negotiating technology trade-offs and assembling microchips in new configurations that resulted in a massive leap in product technology. The initial product results of “deep miniaturization” – the first of what the company hopes is many – has now resulted in the introduction of new, smaller cardiac monitors (the Reveal LINQTM Insertable Cardiac Monitor) and pacemakers (the investigational Micra® Transcatheter Pacing System) that are as small as a vitamin pill. While most of our competitors have long ago outsourced this capability, Medtronic has maintained and continued to invest in internal microchip fabrication expertise to enable vertical integration of traditional microchip design. More importantly, it also allows us to put biological sensors on microchips – an important capability that will be incorporated into future deep miniaturization product designs and follows where cardiovascular care is progressing: smaller devices that provide more clinically actionable data.
What is Medtronic unveiling, or focusing on, at ACC.15?
Coyle: ACC will be an exciting meeting for cardiologists with significant updates of interest across our entire depth and breadth of products, most notably in the valve and stent fields.
It’s an excellent opportunity for cardiologists to learn more about the IN.PACT Admiral drug-coated balloon, which has the potential to change the standard of care for peripheral arterial disease in the superficial femoral and popliteal arteries. The IN.PACT Admiral DCB offers patients a new therapy option that has demonstrated the best clinical outcomes ever reported for this disease state and has been proven to reduce the need for costly repeat procedures that are commonly associated with other available interventional therapies. We received FDA approval for the device in December, and the U.S. launch is underway with an expanded sales force following the completion of our acquisition of Covidien, which is facilitating accelerated access to hospitals, physicians and patients nationwide.
On the TAVR front, we're presenting the two-year data from the High Risk Study of the CoreValve U.S. Pivotal Trial, the one-year data on CoreValve in low- and intermediate-risk patients in the NOTION study, and the first clinical results with the recapturable, next-generation CoreValve Evolut R System. Additionally, the first clinical outcomes from our next-generation TAVR technology, recapturable Evolut R will be featured. We believe the recapturable technology is the future for TAVR technology.
For stents, we’re also making two significant product announcements. First will be the start of the U.S. trial for our next-generation drug-eluting stent, the Resolute Onyx DES. Second, Medtronic will announce the first preclinical data of the novel drug-filled stent (DFS) and our plans to initiate the first-in-man study later this year. Built on a unique platform, the DFS has been designed to address the challenges of newer-generation DES that have bioabsorbable polymers or polymer-free technologies, by providing controlled therapeutic drug delivery to the arterial wall in the absence of a polymer carrier.
For our Cardiac Rhythm and Heart Failure Management business, we will be featuring our latest technology, which is becoming the new standard of care in cardiac monitoring. Our Implantable Cardiac Monitoring system, Reveal LINQ is for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management and our SEEQ, our mobile cardiac telemetry system For patients experiencing frequent symptoms that require short-term monitoring.
How will those improve patient care and/or change practice management?
Coyle: The IN.PACT Admiral drug-coated balloon has delivered exceptional outcomes for patients with PAD in the SFA, which not only causes leg pain but also increases the risk of heart attack and stroke. The DCB arm of the IN.PACT SFA Trial demonstrated the lowest clinically driven target lesion revascularization (CD-TLR) rate ever reported for an interventional treatment of PAD in the SFA, with only 2.4 percent of patients treated with the IN.PACT Admiral DCB requiring a repeat procedure at one year, compared to one in five patients (20.6%) treated with percutaneous transluminal angioplasty (PTA). By reducing the need for repeat procedures, the new device is also proving to be economically attractive. Results from an interim economic analysis of the IN.PACT SFA Trial revealed that treatment with the IN.PACT Admiral DCB is cost-effective compared to balloon angioplasty from discharge through one-year of follow-up, indicating the potential to lower overall healthcare costs over the longer term.
Most notably, the TAVR data announcements at ACC address unanswered questions in contemporary cardiovascular clinical practice. The first question revolves around, "What’s the most appropriate treatment approach–either TAVR or SAVR–for high risk aortic stenosis patients?"
At ACC last year, the CoreValve System showed superior outcomes to SAVR at one year. We’re excited to see if the superiority benefit persists at two years, as we think these outcomes could answer this question once and for all and position self-expanding TAVR as the new standard of care for these patients.
Another critical question is, "Are low- and intermediate-risk aortic stenosis patients suitable for TAVR?" The NOTION study is the first to analyze TAVR vs. SAVR head-to-head in these lower-risk patients. If TAVR with CoreValve proves as safe and effective as SAVR in this trial, and then in larger trials, like Medtronic’s SURTAVI, then we’ll most likely see a significant shift in clinical practice in the years to come that favors self-expanding TAVR.
One of the most remarkable improvements in patient care has been with Implantable Cardiac Monitors (ICMs). ICMs have been proven to be highly effective for the detection of atrial fibrillation (AF). This is highly significant, as patients with AF are five times more likely to have strokes, but their condition often goes undiagnosed because their AF episodes occur only sporadically and may not have any symptoms.
Studies have shown that continuous, long-term cardiac monitoring of cryptogenic stroke patients helps physicians detect and diagnose AF and provide treatment to prevent a recurrent stroke. Medtronic, along with the American Heart Association-American Stroke Association, has launched an education campaign with the goal of reducing the rate of recurrent strokes. In addition, Medtronic has invested in clinical research, including the CRYSTAL AF Clinical Trial, which found that continuous cardiac monitoring with an ICM was superior to standard care at detecting atrial fibrillation (AF) in patients who have had strokes of undetermined causes (cryptogenic stroke).