Cardiovascular Systems, Innova Vascular Partner on Thrombectomy Device Development

Cardiovascular Systems Inc. (CSI) is teaming up with Innova Vascular Inc. (Innova) to develop a full line of thrombectomy devices.
 
Thrombectomy is a rapidly growing interventional procedure performed to remove blood clots from arteries and veins. CSI intends to acquire and commercialize thrombectomy devices from Innova targeting peripheral vascular disease, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Commercialization of the thrombectomy devices will be highly complementary to CSI’s broader portfolio of advanced technologies used in the treatment of cardiovascular disease.
 
“We strive to bring solutions that are easy to use, safe, and highly effective in treating potentially devastating diseases. We are excited to partner with CSI, which has been serving the interventional cardiology, interventional radiology, and vascular surgery communities that will be the primary users of Innova products,” said Sanjay Shrivastava, Ph.D., CEO of Innova. “CSI’s commercial presence in this space makes it an excellent fit for accelerating the commercialization of Innova’s products post regulatory clearances.”
 
Pending regulatory clearance in the United States, CSI could begin to commercialize a portfolio of manual aspiration and clot retrieval devices for the treatment of peripheral vascular disease in its fiscal 2023. The portfolio and corresponding indications for use are expected to be expanded to include treatment of DVT and PE following completion of subsequent clinical trials.
 
“The commercialization of these thrombectomy devices will be an important addition to our growing pipeline of products. In total, developing novel drug coated balloons, intravascular lithotripsy, mechanical circulatory support, and thrombectomy devices target some of the fastest growing segments within interventional cardiology,” said Scott R. Ward, CSI chairman, president and CEO. “Supplementing our core orbital atherectomy devices with these technologies will greatly increase the number of patients we will reach while simultaneously expanding our total addressable market to over $18 billion in the coming years.”
 
Under terms of the agreements signed with Innova, CSI has provided financing to Innova for the development of the thrombectomy devices. Under an acquisition option agreement, upon Innova’s completion of key technical, regulatory and clinical milestones in the development program, CSI will have exclusive rights to acquire the thrombectomy devices, subject to the satisfaction of closing conditions set forth in the agreement.
 
Innova Vascular, Inc. is a medical device company based in Irvine, Calif., that develops minimally invasive solutions to treat arterial and venous thromboembolism. Its product portfolio includes, but is not limited to, Laguna clot retrievers and Malibu aspiration catheters. 
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.