Surmodics Builds Thrombectomy Portfolio with Acquisition of Vetex Medical Limited
Deal adds second FDA 510(k) cleared device to thrombectomy platform
- Easy-to-use, stand-alone, single session mechanical thrombectomy for removal of venous clot in highly attractive, rapidly growing and significantly under-penetrated market
FDA 510(k) cleared (
Dec. 2020) and CE Mark Certification ( May 2021)
12-month follow-up data of 19-patient feasibility trial presented at
American Venous Forum( March 2021) all primary endpoints met with no safety issues1
Surmodicswith two FDA-cleared mechanical thrombectomy devices to treat arterial and venous vasculature and IP for potential indication expansion
The ReVene mechanical thrombectomy catheter is specifically designed to remove large, mixed-morphology blood clots commonly found with venous thromboembolism (VTE). The device’s dual action technology efficiently removes mixed-morphology clot in a single session, minimizing the need for thrombolytics and without capital equipment.
“This acquisition demonstrates our commitment to the expansion of our thrombectomy platform to remove thrombus in venous vascular beds, with an exciting technology that offers significant improvements over current therapies,” said
“The ReVene Thrombectomy Catheter has the potential to significantly expand the use and accessibility of venous mechanical thrombectomy by allowing physicians to intervene early and complete the procedure in a single session,” said
Under the terms of the acquisition agreement,
About Venous Thromboembolism (VTE)
VTE is an underdiagnosed and serious, yet preventable medical condition that can cause disability and death. VTE includes deep vein thrombosis (DVT), which occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh, or pelvis, and PE, which occurs when a clot breaks loose and travels through the bloodstream to the lungs. In
While anticoagulation remains the most widespread therapy for DVT, interventional treatment has demonstrated the potential for better outcomes in select patients. Currently available interventional DVT treatment options include the use of thrombolytic drugs to dissolve clot, with or without the use of a mechanical device, or capital equipment-based mechanical devices that use fragmentation and/or aspiration to create a core through the center of the clot. Purely stand-alone mechanical devices are catheter-based systems designed to capture and remove clot from the venous anatomy. Because thrombolytic agents thin the blood, they present a bleeding risk for many patients and can require prolonged hospital stays and ICU monitoring. Without effective treatment, patients are at risk for pulmonary embolism or long-term complications. Up to 50 percent of patients with symptomatic DVT will develop post-thrombotic syndrome (PTS) within two years, which causes chronic limb pain, swelling, heaviness, fatigue, and in extreme instances, limb ulceration.
The FDA requires specific indications for devices to be marketed for treatment of certain aspects of VTE such as DVT and PE. The ReVene Thrombectomy Catheter is indicated for mechanical de-clotting and controlled and selected infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature. The device currently is not indicated for the treatment of DVT or PE.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about potential expansion of our thrombectomy platform to remove thrombus in different vascular beds, our thrombectomy platform development (and its potential acceleration) for the future treatment of PE, the potential for the ReVene Thrombectomy Catheter to significantly expand the use and accessibility of venous mechanical thrombectomy, the potential for the ReVene Thrombectomy Catheter to significantly expand the use and accessibility of venous mechanical thrombectomy, the potential for the ReVene Thrombectomy Catheter to be a first-line treatment choice, the anticipated financial impacts of the Vetex acquisition, expectation about the timing of initiating clinical evaluation activities, anticipated future disclosures and announcements by the company, and the company’s growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended
1. Black S, et al. VETEX European study of the ReVene Thrombectomy Catheter. Presented at VENOUS 2021, the annual meeting of the
2. Blood Clots: A Serious but Preventable Medical Condition.