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The London Cardiovascular Device Innovation Summit is a day and a half of interactive discussions with full audience participation focused on EU/US innovation pathways for new interventional devices. Leading UK policy makers, NIH and NIHR funders, MHRA and FDA device regulators, VC funders, bioengineers, commissioners, clinicians and both start-up and mature device industry will provide a realistic and global perspective of current pathways and “sticking points” to enable and facilitate cardiovascular device development from early concept to clinical evaluation, market approval and reimbursement.
Our goal is to engage in an open critical dialogue of experts to provide insight into the global landscape of device innovation using specific case based therapeutic areas to discuss issues relevant to innovation:
- UK Policy for investments and incentives for device innovation
- US FDA regulatory reform for early First in Human device studies
- Disparities in premarket requirements for CE Marking – who decides?
- Critical evaluation of the 2008 EMA DES guidance document – time to reconsider?
- EU/US Regulatory harmonization in approval requirements – Case examples
- Funding options for small businesses: NIH, NIHR, and private funds
- New technology appraisal and commissioning: considerations for trial design
Case examples of therapeutic areas include:
- Mitral devices for mitral regurgitation
- Renal denervation for refractory hypertension
- Fully bioresorbable scaffolds for coronary applications
- Neuro-protection devices for TAVR
- Tissue engineered vascular endograft
- Genetically modified bovine pericardium valves
Andreas Baumbach, Alexandra Lansky, John Martin, Anthony Mathur
Michael Cleman, Aroon Hingorani, Pascal Meier, Michael Mullen, Michael Simons, Bryan Williams
Yale School of Medicine and University College London