Innova Vascular: Pioneering Excellence in Minimally Invasive Healthcare

Founded in 2018, Innova Vascular is a pioneering medical device startup dedicated to creating cutting-edge solutions to treat various vascular diseases through minimally invasive methods. Based in Southern California, Innova Vascular is currently focused on transforming the treatments for arterial and venous thromboembolism. The company recently received approval by the US FDA for marketing its Laguna thrombectomy system for removing clots in the peripheral vasculature. These novel products are now being used to treat patients.

Removing Clots Quickly and Safely

Deep vein thrombosis (DVT) occurs when a clot is formed in deep veins, usually in the legs, due to various factors that include a sedentary lifestyle, genetics, or other pre-existing conditions among others. It affects nearly a million individuals in the US annually and approximately 15 million worldwide. In more than half of these patients, a clot gets dislodged from deep veins in the legs and finds its way into pulmonary arteries, giving patients symptoms that resemble those of a heart attack, i.e., chest pain and difficulty in breathing. This condition is called pulmonary embolism (PE). DVT and PE together are referred to as venous thrombo-embolism (VTE). VTE is responsible for about 100,000 deaths in the US alone each year and results in $15 billion in healthcare spending. Removing clots quickly and safely can bring these patients back to a safe condition, but doing open surgeries on these patients can have a high risk of mortality and morbidity. Innova Vascular has developed medical devices that can remove these clots without open surgery. In these procedures, termed thrombectomies, a doctor inserts a needle at the groin and makes way for a long catheter to be inserted into the patient’s vein without the need for open surgery. These catheters are guided into deep veins or arteries as needed. Innova Vascular has developed its pioneering products termed as the Malibu Aspiration Catheter System and the Laguna Clot Retriever System, which enable such a procedure and are used in this way. The Malibu Aspiration Catheter System stands out with excellent navigability and a user-friendly design, allowing operators of all skill levels to remove clots efficiently. Paired with the Laguna Clot Retriever System, it can efficiently address the need for various vessel sizes in various anatomical locations within the peripheral vasculature.

Innova Vascular’s Laguna Thrombectomy System is designed for the non-surgical extraction of emboli or thrombi and for infusing, injecting, or aspirating fluids in the peripheral vasculature. The System offers a comprehensive range of sizes of the Malibu Aspiration Catheter and the Laguna Clot Retriever. The Malibu Aspiration Catheter utilizes a gradient structural design and a hydrophilic coating for excellent navigability through tortuous vessels. It can be used alone or with the Laguna Clot Retriever, which utilizes a self-expanding laser-cut Nitinol design. Radial strength and cell sizes of the retriever are optimized for maximizing clot capture and enabling circumferential clot ingress.

Transforming Medical Care

The medical devices industry relies on understanding unmet clinical needs. Once Innova Vascular deeply understands these needs, it works on creating effective solutions. The company has meticulously structured its product development process, from design conceptualization, design-freeze, rigorous verification and validation procedures, and culminating in receiving approvals from regulatory authorities around the world prior to initiating sales. “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.

Innova Vascular’s strategic partnerships with physicians fostering collaborative relationships that bridge the gap between medical expertise and innovative solutions are vital to this journey. The company also focuses on assembling a team of creative minds, recognizing that the collective efforts of dedicated individuals propel innovation. Ultimately, the synergy of physician collaborations, inventive thinking, and cohesive teamwork drives Innova Vascular’s success in the ever-evolving landscape of medical device development and patient-centered solutions.

“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. Raj Khalsa, Chief of Interventional Radiology at St. Joseph’s Center for Cancer Prevention and Treatment located in Orange, CA, after his early experience with Innova’s products.

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”.

Future Roadmap

Looking ahead, Innova Vascular envisions a future dedicated to ongoing product development for effectively removing clots. The company also anticipates potential collaborations with prominent organizations, and should a major corporation choose to adopt and commercialize its products, this could even pave the way for its acquisition or the continued evolution of advanced tools. Innova Vascular remains fully committed to shaping the future of healthcare by continuously improving its offerings and exploring strategic partnerships to take its groundbreaking innovations to new heights.

The Leader

Sanjay Shrivastava is the founder and CEO of Innova Vascular. With an influential career spanning over two decades, Sanjay has been a driving force in developing, commercializing, evaluating, and acquiring medical devices.

Sanjay’s illustrious career has seen him play leadership roles at several well-known medical device companies, including Senior Director of Business Development at Johnson & Johnson, Vice President of Upstream Marketing and Strategy at BTG, plc., which was later acquired by Boston Scientific Corporation, Director of Global Marketing at Medtronic, and Director of Research and Development at Covidien/ev3.

Sanjay also co-founded BlackSwan Vascular, a medical device company that developed a liquid embolic agent for peripheral vascular applications. BlackSwan entered into a strategic relationship with Boston-based Sirtex Medical in 2020, which completed the acquisition of BlackSwan Vascular in April 2023. Sanjay holds over 30 US and several other international patents in medical devices. He has also edited two books, including “Medical Device Materials” published by ASM International.

Sanjay’s academic journey commenced at IIT Roorkee, India, followed by a transformative scholarship that brought him to the United States. Here, he pursued a Ph.D. in Material Science and Engineering at the University of Florida.