This partnership offers BiO2 Medical a hydrophilic and lubricious coating to enhance ease of placement and reduce access site trauma for the Angel catheter, a central venous access catheter (CVC) with a permanently attached inferior vena cava (IVC) filter.
BiO2 Medical’s Angel catheter is intended to provide IVC filter protection from pulmonary embolism immediately following admission to the intensive care unit, while simultaneously allowing for central venous access in critically ill patients.
The design of the Angel catheter incorporates the pulmonary embolism protection of a retrievable, Nitinol IVC filter, permanently attached to a triple lumen, central venous access catheter.
BiO2 Medical research and development vice president Jeff Steinmetz noted this partnership allows the company’s flagship product, the Angel catheter, to be easily placed at the patient’s bedside by the attending physician due to DSM’s hydrophilic and lubricous coating technology.
"We partnered with DSM due to their highly regarded technical support, responsiveness, and ability to meet project timelines," Steinmetz added.
BiO2 Medical has obtained CE Mark approval for its Angel catheter and the device is currently commercialized in Europe and the Middle East.
BiO2 Medical claims it is the first IVC filter to receive CE Mark approval for a prophylactic use indication, in addition to traditional IVC filter and central venous catheter indications.
The device is also the subject of an US Food and Drug Administration Early Feasibility Pilot Study Program which will enroll approximately 10 patients.
Initial results of the study program are anticipated to become available in the second quarter of 2014.
