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

Article perview reprinted from IN VIVO - June 2009

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. Read more...

AccessClosure: FDA Clearance--Yes; Product Launch--Not Yet
Article perview reprinted from IN VIVO - June 2009

Sometimes just getting FDA approval isn't enough. This start-up got FDA clearance of its PMA vascular closure device, only to delay the product's launch in order to develop an improved version. The risk appears to be paying off.

• For most device start-up companies, obtaining FDA clearance of a PMA product is a cause for celebration and leads to immediate US commercialization.

• For AccessClosure, a vascular closure device company started by serial entrepreneurs Fred Khosravi and Amar Sawhney through their Incept development organization, FDA clearance presented a dilemma because physicians complained the product wasn't easy to use.

• The company decided to delay the launch, forestalling one-and-a-half years of revenue, to address physicians' concerns and introduce an improved product.
• The decision appears to be paying off as the company is seeing rapid adoption even though its product is priced at a premium.

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Companies included in this article:
Abbott Laboratories Inc., Abbott Vascular Devices, AccessClosure Inc.,Boston Scientific Corp., Covidien Ltd., Confluent Surgical Inc., St. Jude Medical Inc.

Related articles:

• Fred Khosravi & Amar Sawhney: Dynamic Device Development Duo, IN VIVO 6/2009
• Interview with Amar Sawhney, IN VIVO 6/2009
• Vascular Access Closure Ten Years Later: Why Start-Ups Can't Seal the Deal, Start-Up 12/2008
• An Open Market for Vascular Access Closure Devices, Start-Up 5/2004

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