“This marks an important advance in the management of critically ill patients everywhere. The ability to protect from pulmonary embolism and resuscitate with one device is unique.”
In short
Texas based medical device manufacturer BiO2 Medical, Inc., has announced the first-in-man clinical study for its innovative Angel™ Catheter/IVC Filter. The study is being conducted under IRB approval at two medical centers in Medellin, Colombia, Clinica Las Americas, and Hospital Pablo Tobon Uribe. According to a company press release, eight critically ill patients have been enrolled in the study thus far.
Background
According to BiO2, its Angel™ Catheter, invented by one Dr Angel, MD is a “truly retrievable” Inferior Vena Cava (IVC) filter that is permanently attached to a multi-lumen central venous access catheter. It is intended for use in critically ill patients with Venous Thrombo-Embolism (VTE) disease who are at increased risk of pulmonary embolism(PE), but for whom anticoagulation therapy is temporarily contraindicated.
The design of the Angel™ Catheter allows for easy insertion and access to the central venous system for administering medications, fluids, or blood products; blood sampling; and monitoring of central venous pressure.
The Angel™ Catheter is intended to be used during the critical time period in which anticoagulation therapy poses a high risk of complications, including major bleeding and death, and in which patients are at highest risk of VTE. The filter can be easily removed when the central line is removed, once the danger of VTE has been resolved.
This device cleverly piggybacks on the procedure to insert a central line, and allows for the placement of a truly temporary IVC filter as a means of PE prophylaxis in patients deemed to be at the highest risk for complications with anticoagulation therapy and frequently too sick to be moved outside the ICU for placement of an IVC filter. In so doing the company believes its device will allow for substantially improved PE prophylaxis and the potential for a worldwide reduction in the rates of PE-related mortality and morbidity.
The first in man study is an important milestone for the company as it will provide vital data regarding the safety of the Angel™ Catheter in a clinical setting, which will be instrumental in facilitating clinical adoption of the device.
Clinician comments
Dr. Cadavid and Dr. Gil, the principal investigators in the first in man clinical study, commented on the ease of bedside insertion of the Angel™ Catheter in a procedure that resembles a routine central venous catheter placement. Both principal investigators feel that the Angel ™ Catheter fills an important clinical need for an Inferior Vena Cava filter designed for use in critically ill patients at high risk of pulmonary embolism (PE).
Dr. John A. Kaufman from the Dotter Interventional Institute and a member of BiO2 Medical’s clinical advisory board said, “This marks an important advance in the management of critically ill patients everywhere. The ability to protect from pulmonary embolism and resuscitate with one device is unique.”
Company comments
BiO2 Medical’s Chairman and Chief Executive Officer, Christopher E. Banas, commented on the initiation of the clinical study, “We are proud to be providing a lifesaving technology for critically ill patients at risk of PE, and this study demonstrates that this device is safe for use.”
SOURCE BiO2 Medical, Inc., PR Newswire
published: March 29, 2012 in: Cardio, Clinical Studies/Trials, Products