Bio2Medical reports first commercial placements of its Angel Catheter in U.S.
Thursday October 6, 2016 0 comments
GOLDEN -- Bio2 Medical announced its Angel® Catheter, a new device for the prevention of pulmonary embolism (PE), was placed in two patients at St. Mary's Mediczl Center in West Palm Beach, Florida, by Lawrence Lottenberg, MD FACS, and Robert Borrego, MD FACS, on Sept. 29.
It is the first commercial usage of the Angel Catheter and St. Mary's Medical Center of Tenet Health is the first hospital in the United States to place the device, the company said.
The Angel Catheter received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as the first-ever, prophylactic indication for a medical device to protect critically ill patients at high-risk for pulmonary embolism and contraindicated for anticoagulation.
The first patient was at high risk for PE due to traumatic brain injury post craniotomy. The second patient had prolonged immobilization due to a cervical spinal cord injury and quadriplegia. Both patients were contraindicated to prophylactic anticoagulation for 7-10 days.
The Angel Catheter was placed at the bedside in the trauma ICU, without the need for fluoroscopic guidance, allowing Dr. Lottenberg and Dr. Borrego to provide their patients with immediate PE prophylaxis.
"The Angel Catheter provides an unmet need for a prophylactic indication for the prevention of pulmonary emboli,” said Lottenberg.
“Unlike traditional filters, the Angel Catheter cannot migrate from its deployment position, and it is easily inserted and easily removable for patients who cannot be prophylactically anticoagulated during the immediate and early phases of injury.
“There are none of the complications seen in the many currently available inferior vena cava filters. This makes the device unique and one of a kind. The recognition of the value of this technology to patient safety and patient care by the Tenet Healthcare System and St. Mary's Hospital in bringing this technology to our Level I trauma cannot be overstated."
"The placement of the Angel Catheter at the bedside is a safe and efficient way to protect patients at high risk for pulmonary embolism, who cannot be anticoagulated for seven to ten days, therefore protecting them from additional morbidity/mortality due to pulmonary embolism in high-risk patients," said Dr. Borrego.