The U.S. medical device arena is in danger of ceding the throne to countries with friendlier regulatory environments but the system is not irreparable, Dr. Martin Leon said during a lecture at this week’s Transcatheter Cardiovascular Therapeutics symposium in San Francisco.
U.S. device makers need to evolve, reorganize and globalize to adapt to an ever-changing government landscape to remain competitive with the rest of the world, said Leon, director of New York-Presbyterian Hospital/Columbia University Medical Center’s interventional vascular therapy department.
Over the last 6 years domestic med-tech startup valuation and health funding sank by more than half, Cardiovascular Business reported. VC funding has gone down by a quarter and private-equity dollars are less by 65 percent.
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Leon pointed to several regulatory and economic pressures, including cost-sensitivity in the marketplace and a widening gap between U.S. and European review processes, as forces of change that have left an indelible mark on the interventional cardiology field.
With timelines for FDA clearance growing and the cost to bring a device to market heavily going toward FDA related or dependent aspects of the process, Leon urged device makers to consider how to shift thinking to adapt to the new order.
Device makers need to accept that the U.S. innovation ecosystem has changed and evolve in light of it, Leon recommended. Furthermore, the physician scientist community need to reorganize to establish a stronger community with better pathways for communication. Lastly, innovation must go global, including everything from concept development to commercialization.
Here’s a look at some other results coming out of the TCT 2011 conference:
Cardiovascular Systems: Diamondback arterial plaque remover beats angioplasty
Cardiovascular Systems (NSDQ:CSII) touted results from the Compliance 360° trial of its Diamondback 360° atherectomy system in removing buildup from severely calcified lesions above the knees. Read more
Abiomed: Impella improves quality of life
Abiomed (NSDQ:ABMD) revealed the final analysis from its Protect II trial of its Impella support system, finding it led to a reduction in adverse events in and out of the hospital as well as repeat vascularization.
OrbusNeich: Genous stent bests others in rapid healing
OrbusNeich’s Genous stent bested other devices, including stents made by Terumo and Disa Vascular, in providing the most rapid healing at 14 days post implantation. Read more
Elixir: Trial data proves DESyne drug-eluting stent safe and effective
Elixir Medical Corp. revealed 6-month trial results proving the safety and effectiveness of its DESyne BD Novolimus-eluting stent compared to Medtronic’s Endeavor Zotarolimus-eluting stent.
Micell Technologies: MiStent trial data released
Micell Technologies Inc. unveiled results from its Dessolve I study of the MiStent Sirolimus-eluting stent at 4, 6 and 8 months.
InSeal Medical: Sealing large bore punctures in vessels from the inside
InSeal Medical Ltd. announced that its next generation vascular closure device for large bore punctures proved successful in patients.
Biosensors International Group: First-in-man study proves BioFreedom polymer-free DES effective
Biosensors International Group Ltd.’s BioFreedom polymer-free drug-eluting stent proved similar to Boston Scientific’s Taxus Liberte stent after two years. Read more
And check out these briefs from TCT Daily:
- Everolimus-eluting stents compare favorably to sirolimus-eluting stents in two pivotal trials
- Caution urged in widespread adoption of transcatheter aortic valve replacement
- Study finds no difference between zotarolimus-eluting and everolimus eluting stents in patients with acute coronary syndrome
- Long-term outcomes improved with biodegradable biolimus-eluting stent vs. permanent polymer sirolimus-eluting stent
- Polymer-free DES shown effective in multiple trials