The number of interventional cardiology technologies is growing, and these devices will require clinical implementation, improved performance and standardized regulatory processes for worldwide patient benefit. These challenges are apparent in western medicine, and partnerships such as the Yale-UCL collaborative have been developed to facilitate EU-US innovations in cardiovascular medicine.
Engineering considerations, trans-Atlantic regulatory procedures, healthcare policies, funding of innovative devices, and most importantly, clinical needs, were all addressed recently at the Yale-UCL Cardiovascular Device Summit (18th-19th Jan), which BMC Medicine was pleased to attend. Political interest in this issue was clear as the opening address of this influential meeting was given by George Freeman, Member of UK Parliament and Government Advisor on Life Sciences, who highlighted that innovative research in translational and patient-centered medicine through collaborations with the NHS, academia and industry will help drive a competitive economy.
The meeting was chaired by Alexandra Lansky and Michael Mullen, and key presentations were delivered by major funding and regulatory bodies including NIHR, NIH, NHS, FDA and MHRA, engineers from Medical Technology companies and interventional cardiologists.
Discussions on percutaneous coronary intervention included second generation trans aortic valve implantation (TAVI), mitral valve devices, novel biodegradable stents and targeted biologics. The Edwards SAPIEN Transcatheter Heart Valve has been used in Europe for several years with recent approval of its use in the USA following the publication of the PARTNER 1 trial. The next generation Edwards SAPIEN XT transcatheter heart valve is currently being tested in a Phase III PARTNER 2 trial. However, concerns of the higher rate of cerebral stroke following TAVI were addressed in an entire session on neuroprotection and included talks by Alexandra Lansky and Andreas Baumbach.
A compelling session on drug-eluting stents (DES) showed that the next generation stents will require improved delivery, lower drug quantities, less polymer and decrease risk of thrombosis. The fully bioresorbable stent technology allows positive remodeling after angioplasty of the injured artery and the first trial to determine the safety of this technology in man started (ARTDIVA study). Additionally, the magnetic biodegradable stent is currently being investigated in a large EU funded BIOMAGCAR project.
Other topics discussed at the summit included vascular and uterine artery gene therapies, non-invasive blood pressure monitoring device (Bpro) and novel imaging techniques for coronary disease. The meeting concluded on the use of computational models and new engineering tools to help generate patient specific devices, an important aspect for personalized medicine.
Overall, it seems that the clinical, political and economic collaborations of this prominent meeting will help promote government incentives, global networks, regulatory reform and industrial partnerships for innovation in academia. The ultimate goal is of course to improve interventional cardiology treatment options for patients, and the strategic partnership between the clinicians and engineers involved in the Yale-UCL collaborative project appears to be a step in the right direction.