Interventional cardiology is a specialty that owes its very existence to medical device innovation, for without the development of transcatheter technologies, percutaneous coronary interventional (PCI) procedures would not be possible. And, among all specialists, interventionalists remain arguably the most voracious early adopters of new technologies and techniques even as that market’s growth slows. Fitting then that, once again, this year’s PCR conference – Europe’s largest interventional cardiology meeting, held annually in Paris in May – kicked things off with its annual Innovators Day (ID), a day-long gathering of clinicians, engineers, entrepreneurs, industry executives and investors – all of the key elements that combine to create the medtech innovation ecosystem. (Note: The editors of MedTech Strategist are members of the PCR Innovators Day steering committee and participated in the event.)

The accompanying interview with cardiologist Bernard Prendergast, MD, of London’s Guy’s and St. Thomas’ Trust, a PCR faculty member and director of the PCR London Valves conference, highlights how innovation has become an important part of the PCR family of meetings by virtue of it being such an integral part of the practice of cardiology. For example, this year’s ID in Paris featured a panel on digital health and a keynote address by Pascal Gene of IBM Watson Health on big data and artificial/ augmented intelligence (AI). “Clearly the power of digital media and computing is extraordinary, and what can be achieved goes beyond the imagination of most clinicians,” Prendergast observes, pointing out that the ID sessions covered not only the therapeutic applications of these solutions to treat disease, but also to monitor the health of both individual patients and large populations. Among the presenting digital health companies were Cardiologs (cloud-based platform using AI for ECG analysis) and HealthWatch Technologies (textile medical sensor technology, including a 12-lead ECG digital smart garment).

The Innovators Day program also included advances in traditional clinical cardiovascular applications such as stroke prevention, atrial fibrillation (AF) and left atrial appendage (LAA) closure, and heart failure (HF), along with advances in diagnostic imaging. The imaging session featured FEops (personalized computational modelling for structural heart interventions), CorFlow Therapeutics (a new way to understand the coronary microcirculation to improve heart attack outcomes), and Philips (early work on radiation-free interventions). Other companies presenting new clinical tools included Biomodex (structural heart patient-specific planning system), CardioCorX (catheter-based device to isolate the LAA in AF and HF patients), and AuriGen Medical (next-generation LAA implant technology). In heart failure, featured companies included Endotronix (Cordella HF system with implantable wireless pulmonary artery pressure sensor), Magenta Medical (transcatheter renal venous decongestion system), Paragate Medical (implantable peritoneal ultrafiltration), Sequana Medical (implantable system for direct sodium removal to manage fluid overload), and Procyrion (Aortix micro-axial flow pump).

Please visit https://www.pcronline.com/Cases-resources-images/Resources/Educational-interviews/Best-of-PCR-Innovators-Day-Paris-2018 for the original report.

One clinical space that was not explored as deeply in Paris as in years past was transcatheter heart valves. There was a session on emerging technologies for aortic stenosis that saw presentations by ShockWave (trans-aortic valve lithotripsy), Pi-Cardia (a non-implant based treatment for aortic stenosis), and Xeltis (restorative heart valves). Prendergast points out that the absence of coverage of new mitral and tricuspid devices was by design. “We didn’t focus on valves specifically at this meeting because we plan to concentrate on the latest innovations at London Valves later this year [September 9-11],” he explains. In anticipation of that meeting, Prendergast goes on to point out that “There is still a huge pipeline of innovation, particularly addressing mitral and tricuspid valves, where we don’t have perfect solutions.” Those valves also present much more challenging anatomical issues than aortic valves, and as a result, many patients are not anatomically suited for current devices, placing a premium on developing new technologies and delivery approaches. “We also need to make progress in making the current solutions easier and more practical for more clinicians,” he adds, pointing to current efforts to develop transseptal delivery methods as a potential approach that would help ease that situation.

Perhaps the best example of the breadth of technologies covered during this year’s Innovation Day was the session on bioresorbable (BR) stents/scaffolds. No cardiovascular product segment has suffered greater disappointment in recent years than BR scaffolds, with Abbott Vascular withdrawing its Absorb BR stent from the market last year after having spent in excess of $1 billion on its development, and Boston Scientific discontinuing its Renuvia BR stent, all in the face of disappointing clinical results. Yet, efforts to develop a safe and effective bioresorbable stent that delivers superior clinical results continue, perhaps surprisingly, on the part of start-up companies. The ID session included presentations from Stentit, Hartlon, Elixir Medical, S-Bahn Medical, and Japan Medical Device Technology, all working on different varieties of and approaches to bioresorbable/regenerative scaffold design.

Prendergast acknowledged that many clinicians are of the view that BR scaffolds “are dead in the water.” Yet, the Innovators Day presentations provide a contrarian view on the part of the engineers, entrepreneurs and investors involved with those companies, indicating that research and development continues in that space. He notes that lessons have been learned from the disappointing results of the past few years, with engineers going back to the drawing board to design scaffolds with thinner struts and increased radial strength. In his view, “These presentations demonstrate there is much to look forward to because there is patient-led demand for devices that resorb and will no longer remain in the body.” Prendergast adds that cardiologists are also still seeing challenges associated with prolonged anti-platelet therapy that isn’t practical in many patient groups and could be avoided with BR scaffolds. (Also see this recent post on our Community Blog, Post-Absorb: REVA Medical Moves Forward in Bioresorbable Scaffolds.)

The session on bioresorbable scaffolds also reflected the global nature of medtech innovation that was on display throughout the course of Innovators Day, reflected in both the presenting companies and attendees. In that way, ID was a microcosm of both the Paris PCR meeting as a whole with its nearly 11,000 attendees coming from all parts of the world, and the entire PCR community, which has expanded the reach of its meetings from Europe to Asia, the Middle East and Africa. “Innovators Day highlights that medical innovation is very much a global activity, but also that we are working in a smaller and smaller world, where we are able to communicate our ideas and developments in a very rapid fashion,” says Prendergast. “That speaks to the fact that innovation is in a very healthy state.”

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