Vascular access system maker Avenu Medical said last Friday it won a HCPCS C-Code from the Centers for Medicare and Medicaid Services for its Ellipsys dialysis device and the endoAVF procedure. The San Juan Capistrano, Calif.-based company’s Ellipsys vascular access system device is designed for use with end-stage renal disease patients who require hemodialysis. The system, which […]
FDA grants de novo clearance to Avenu Medical for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won FDA de novo clearance for its Ellipsys vascular access system designed for use with end-stage renal disease patients who require hemodialysis. The San Juan Capistrano, Calif.-based company touted that its Ellipsys EndoAVF technology acts as an alternative to traditional AV fistula creation. The system, which can be […]
FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical
The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical. The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; […]
Avenu Medical raises $13m
Vascular access system maker Avenu Medical has raised $13.1 million in a new round of equity financing, according to an SEC filing posted this week. The company has not yet stated how it plans to spend funds raised in the round or when it plans to close the round. Money in the round came from 77 unnamed […]
Avenu Medical wins CE Mark for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won CE Mark approval in the European Union for its Ellipsys vascular access image-guided catheter system designed to percutaneously create arteriovenous fistulas for hemodialysis access. The company also said it won investigational device exemption approval from the FDA for the device, claiming it is the 1st device […]
Avenu Medical pulls in $6m for Ellipsys AV fistula device
Vascular access system maker Avenu Medical raised $6 million in a new round of debt financing, according to an SEC filing. Avenu Medical, founded in 2010, is developing and producing the Ellipsys vascular access image-guided catheter system, designed to percutaneously create arteriovenous fistulas for hemodialysis access. Funds came from 46 anonymous investors, according to an SEC […]
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