In 2008, the U.S. surgeon general released a “call to action” to the medical community highlighting the need to develop effective prevention measures for DVT and PE, collectively known as venous thrombosis. Approximately 45 million Americans have three or more risk factors for DVT, and PE has been identified as the most common preventable cause of hospital death. DVT is the formation of a blood clot in a deep vein, most commonly located in the legs. PE is the blockage of a main artery of the lung.
According to the company, Vpulse provides intermittent sequential therapy that reduces the risk of hospital-acquired DVT and PE; intermittent dynamic compression therapy reduces swelling at the treatment site; and controlled cold therapy reduces pain and swelling at the treatment site.
“Each of these separate therapies is considered critical in reducing the risk of DVT complications and conducting effective post-operative rehabilitation,” said Howard Edelman, general manager of Cothera. “The fact that the Vpulse can be used continuously from the hospital to home setting, while providing physicians with compliance data via a data card—we believe this will dramatically reduce instances of DVT complications.”
DVT is among the most frequent hospital-acquired conditions. Though many professional associations and hospitals have developed DVT/PE prevention recommendations and protocols, until now there hasn’t been an economically feasible medical device that allows for continued compliance that transitions from hospital to home use under the advice of a physician, Cothera officials claim.
DVT risk is greatest between two and five days after surgery, with a second peak risk period occurring about 10 days after surgery—usually after the patient has been discharged. Given the majority of DVT episodes occur post-discharge, the Vpulse system will be available to help hospitals and clinicians control and reduce readmission related costs.
Predicate devices for Vpulse are Thermotek Inc.’s Nanotherm and Vascutherm.