In short
Three weeks ago BiO2 was trumpeting the first use of its Angel Catheter in a UK hospital, post CE marking. In another demonstration of the contrast between the US and EU regulatory hurdles, the company is now announcing that the US FDA has granted it an IDE approval under its new early feasibility rules, to commence a stateside pilot study for the device.
Background
Earlier this week we wrote about Medtronic’s new stent graft being allowed into US clinical study under the FDA’s Early Feasibility Pilot Study (EFPS) rules. Find that piece here. In it, we talk about how the new rules are intended to allow more early stage clinical data to be gathered on new devices as a pilot to full clinical study for regulatory approval purposes. The EFPS program should provide manufacturers, as well as FDA device reviewers’, a foundation to establish criteria for device modifications and/or protocol development for subsequent clinical studies. The result ought to tick the dual boxes of safe and effective products, with expeditious availability for the patients that need them.
Texan device company BiO2 is going down the EFPS route with its Angel catheter.
The Angel Catheter is the first to combine the functions of an Inferior Vena Cava (IVC) Filter and a multi-lumen Central Venous Catheter (CVC) for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is designed to be placed in the inferior vena cava, at the patient’s bedside, without the need for fluoroscopy.
The Angel Catheter was the first IVC Filter to receive CE Mark approval for a prophylactic indication, in addition to traditional IVC Filter & CVC indications.
The primary objective of BiO2 Medical’s EFPS clinical trial is to obtain continued insight into the safety of the Angel Catheter in critically ill patients with high risk of Venous Thromboembolism disease.
Company comments
According to Christopher E. Banas, BiO2 Medical’s Chairman and Chief Executive Officer, “With this program, the FDA’s forward thinking approach will allow innovative technologies, like the Angel Catheter, to become available for patients in the U.S. in a more expeditious manner.”
Physician comments
According to John A. Kaufman MD, Director of the Dotter Interventional Institute, Portland Oregon, “The Early Feasibility studies are a welcome innovation that will allow physicians, industry, and the FDA to accomplish the shared goal of bringing new devices to Americans in an expeditious and safe manner. This is a great example of how close collaboration between industry and the FDA can lead to a vastly improved process and benefit our patients.”
Source: BiO2 Medical, Inc., PR Newswire
