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An Open Market for Vascular Access Closure Devices

This article was originally published in Start Up

Executive Summary

After an initial warm welcome for first-generation femoral artery closure devices--including a few high-profile exits--sales have stalled. Early devices are flawed, indicating the technical challenge is tougher than it looks. A dozen or so start-ups are trying to address the technology problems that have hampered the pioneers. The newcomers face high hurdles as early experience with first generation devices temper clinician and investor enthusiasm. All will have to prove, in large, rigorous clinical trials, that devices are more complication-free and are as easy-to-use as market leader Angio-Seal, and that they're at least as safe, if not safer, than manual compression. But although start-ups face a great of skepticism about particular technologies, they also inherit a $350 million market made up of devices with an average selling price of $200, which is an endorsement of this new device market. At the same time, an enormous opportunity remains in the 75% of the market that remains unpenetrated.

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AccessClosure: FDA Clearance--Yes; Product Launch--Not Yet

Sometimes just getting FDA approval isn't enough. AccessClosure got FDA clearance of its PMA vascular closure device, only to delay the product's launch in order to develop an improved version. The company forestalled one-and-a-half years of revenue to address physicians' concerns and introduce an improved product. This was particularly wise in the field of vascular access closure devices, where previous devices have disappointed. The decision appears to be paying off as the company is seeing rapid adoption even though its product is priced at a premium.

Vascular Access Closure Ten Years Later: Why Start-Ups Can't Seal the Deal

Despite the best intentions and brightest innovation, start-ups haven't been able to tap into the huge potential presented by the vascular closure market. Ten years after the first generation devices made it to market, the original two leaders still dominate despite the limitations of their devices, while many start-ups have come and gone. A long list of new hopefuls believe they have the solution physicians have desired. Now all they have to do is convince the physicians, who, when it comes to vascular closure devices, are slow to recognize clinical data but quick to embrace a device that feels right to them.

Vascular Access Closure Ten Years Later: Why Start-Ups Can't Seal the Deal

Despite the best intentions and brightest innovation, start-ups haven't been able to tap into the huge potential presented by the vascular closure market. Ten years after the first generation devices made it to market, the original two leaders still dominate despite the limitations of their devices, while many start-ups have come and gone. A long list of new hopefuls believe they have the solution physicians have desired. Now all they have to do is convince the physicians, who, when it comes to vascular closure devices, are slow to recognize clinical data but quick to embrace a device that feels right to them.

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