Plano, Texas-based Cothera LLC recently announced it received newly granted independent certification ISO13485:2012, which validates the quality and safety of its medical devices and technology based on key aspects related to the process of development, design, and production of the devices.
Among Cothera’s certificated devices is the VPULSE System, a medical device designed to assist patients in post-surgery rehabilitation and deep vein thrombosis (DVT) prevention, which is a hospital-acquired condition.
The VPULSE System is a patient-accessible control unit that delivers three different therapies in order to prevent venous thromboembolism and reduce swelling and pain.
The device allows patients to recover at home without suffering any of these post-surgery complications. Until now, hospitals had developed protocols to prevent DVT and pulmonary embolism, but they were only effective for the internment period at the hospital, and post-discharge patients were frequently readmitted at the hospital with DVT complications.
In this way, VPULSE helps both patients and hospitals with home-transition on a treatment-planned basis.
The certification comes after Cothera received a CE Mark certification. CE is a European certification (Conformité Européenne) granted to all products that meet the EU’s health, safety, and environmental standards.
Howard Edelman, general manager of the company, said that these certifications are extremely important considering the company’s new presence in the market, and validates “Cothera’s commitment to provide our customers with outstanding high quality products and broadens our path to increase international sales.”
Cothera was founded in 2012 in response to the market’s need for viable, effective DVT and PE prevention devices.