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Approximately one million individuals in the US experience deep vein thrombosis (DVT), which results from the formation of unwanted blood clots in deep veins, usually in the legs. In around 600,000 of these cases, the blood clot gets dislodged from the veins in the legs and creates an obstruction in the pulmonary arteries, leading to pulmonary embolism (PE). PE prevents the normal flow of deoxygenated blood into the lungs and causes blood pooling in the right side of the heart.

Efficiently, quickly, and securely eliminating a significant volume of these clots from the body represents the pinnacle of innovation in vascular interventions.

Innova Vascular, a medical device company, is a pioneer in developing innovative minimally invasive solutions to treat arterial and venous thromboembolism, pushing the boundaries of what's possible in patient care. Its two products, the Laguna Clot Retriever System and the Malibu Aspiration Catheter System, collectively known as the Laguna Thrombectomy System, have received US Food and Drug Administration (FDA) 510(k) clearance for their use in the peripheral vasculature.

The Malibu Aspiration Catheter System is a singlelumen catheter with a two-way flow control valve at the proximal end. It provides excellent navigation and userfriendly operation, enabling operators of any skill level to effectively eliminate clots. This exceptional ability of the product is a result of intricate knowledge of material science and advanced technology to create intricate designs using a range of polymeric and metallic materials.

The aspiration catheter is also coupled with a laser-cut clot retriever—a technology proven effective in acute ischemic stroke scenarios. This demonstrates Innova Vascular’s expertise in diverse medical applications. When combined with the Laguna Clot Retriever System, it adeptly meets the requirements across a spectrum of vessel sizes and anatomical locations within the peripheral vasculature.

Our mechanical devices are designed to replace traditional surgeries, allowing them to address various body plumbing issues through minimally invasive procedures that avoid major incisions

“Our mechanical devices are designed to replace traditional surgeries, allowing them to address various body plumbing issues through minimally invasive procedures that avoid major incisions,” says Dr. Sanjay Shrivastava, founder and CEO of Innova Vascular.

Using aspiration catheters and clot retrievers, an operator accesses the patient's veins, particularly the femoral vein near the groin. These devices travel under image guidance from the groin to the lungs, efficiently removing clots. Patients typically experience improvement right after the procedure, with the right ventricle returning to normal size within 24 to 48 hours, leading to a quick recovery.

In acute ischemic stroke, the clot retrievers have shown that an operator could open vessels in 95 percent of patients, resulting in at least two-thirds of them experiencing meaningful neurological improvement. This breakthrough was so impactful that the American Stroke Association declared that the standard of care for acute ischemic stroke should involve the removal of clots using clot retrievers. This announcement marked a significant advancement and a substantial contribution to addressing what was previously a devastating disease.

A case in point is when Dr. Raj Khalsa, chief of interventional radiology at St. Joseph’s Center for Cancer Prevention and Treatment in Southern California, requested Innova Vascular’s product for assistance in a critical procedure on a patient with a severe pulmonary embolism. The team promptly supplied the product, and despite the challenging nature of the case, the patient was successfully treated. “Beautifully engineered device with easy prep, excellent trackability in challenging anatomies, and highly effective clot extraction. The design, with simplicity in mind, is a significant advantage in high-risk procedures,” said Dr. Khalsa after this early experience. The patient's condition significantly improved during the procedure, with a notable drop of 16 points in systolic blood pressure right at the table after removing clots from the patient's lung. Following the procedure, the patient's oxygen saturation level reached an impressive 98 percent, showcasing the positive impact of the treatment. Dr. John Moriarty, Professor of Interventional Radiology and Cardiology and vice chair of clinical research at UCLA David Geffen School of Medicine, also added after his experience with Innova products, “The Laguna Thrombectomy System is a valuable addition to the existing therapeutic options for venous thromboembolism. The system offers excellent navigability and ease of use, enabling operators at all skill levels to remove clots efficiently. The system addresses the need for large volume clot removal in a range of vessel sizes in various anatomical locations within the peripheral vasculature”.

Encounters like these are immensely gratifying for Innova Vascular’s team, as they underscore the meaningful impact of their work on patient outcomes. Witnessing positive results like these validates the importance of what they do and is a constant source of motivation for the team. As part of its ongoing efforts, every 3 to 5 years, the company targets a specific organ or part of the body, devising tools to address plumbing issues within the body's infrastructure.

As the company continues its commitment to advancement, it remains dedicated to refining and expanding its arsenal of tools, ensuring a lasting positive influence on healthcare outcomes and reaffirming its position at the forefront of medical innovation.