BiO2 Medical says the pivotal investigation into its Angel® Catheter, has successfully achieved its target of 150 evaluable patients as of December 02, 2015.
Background
The Angel® Catheter features the rapid and acute protection of a retrievable Nitinol IVC Filter, permanently attached to a multi-lumen Central Venous Catheter, which simultaneously provides PE prophylaxis and central venous access for patients at high risk of PE. The novel design of the Angel® Catheter allows for placement directly at the patient’s bedside without the need for fluoroscopy and significantly reduces the complications of traditional IVC filters by ensuring 100% removal of the IVC filter when the catheter is retrieved.
BiO2 Medical says its pivotal study has exceeded original forecasts and concluded one year earlier than anticipated. The early completion of The Angel® Catheter Clinical Trial is being touted by the company as confirmation that physicians are accepting the device.
Investigator comments
The lead primary investigator of the trial provided the following comment: “We are very excited about completing this pivotal U.S. trial. We have found that physicians are very enthusiastic about an IVC filter that can be placed at the bedside in patients at very high risk for acute DVT/PE, or those with VTE who temporarily cannot be anticoagulated. This novel device may not only protect patients from death from acute PE but also could dramatically reduce the number of patients who are sent home with an IVC filter. We look forward to further analyzing the data.”
Source: PR Newswire
published: December 21, 2015 in: Clinical Studies/Trials, News