FDA grants 510(k) approval for Angiotech central venous catheter
Angiotech Pharmaceuticals, a pharmaceutical and medical device company, has received 510(k) clearance from the FDA to market its 5-Fluorouracilcoated (5-FU) central venous catheter (CVC).
The 5-FU CVC is the company’s first drug-eluting medical device product to be researched and developed completely in-house by Angiotech’s research and development and clinical teams, without the aid of a corporate partner, according to William Hunter, MD, president and CEO of Angiotech.
The clinical data from Angiotech’s 960-patient clinical trial, comparing its 5-FU CVC with a chlorhexidine/silver sulfadiazine coated-CVC, met its primary non-inferiority endpoint and there were no occurrences of clinically evident blood stream infection in patients treated with Angiotech’s 5-FU CVC, according to the Vancouver, British Columbia-based company.
The 5-FU CVC is the company’s first drug-eluting medical device product to be researched and developed completely in-house by Angiotech’s research and development and clinical teams, without the aid of a corporate partner, according to William Hunter, MD, president and CEO of Angiotech.
The clinical data from Angiotech’s 960-patient clinical trial, comparing its 5-FU CVC with a chlorhexidine/silver sulfadiazine coated-CVC, met its primary non-inferiority endpoint and there were no occurrences of clinically evident blood stream infection in patients treated with Angiotech’s 5-FU CVC, according to the Vancouver, British Columbia-based company.