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FDA grants breakthrough device designation to new chronic venous insufficiency device - Cardiovascular Business

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Hancock Jaffee Laboratories, a California-based healthcare technology company focused on cardiac and vascular conditions, has received the FDA’s breakthrough device designation for its VenoValve device for chronic venous insufficiency.

The company's first-in-human study, shared with the public in December 2020, found that VenoValve was associated with significant improvements in reflux, disease manifestations and pain following surgery. In addition, there were no material adverse events 30 days after implantation.

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FDA grants breakthrough device designation to new chronic venous insufficiency device - Cardiovascular Business
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