Innovative New Solution Expands Options During Critical Venous Thromboembolism

Early clinical cases, using an innovative new thrombectomy solution distributed exclusively by Varian, highlight its trackability and ease in navigating challenging anatomy to remove clots.

Bulent Arslan, MD, FSIR, Professor and Chair, Vascular and Interventional Service Lines, Rush University Medical Center, shared details at the Global Embolization Symposium and Technology (GEST 2024) conference about the early clinical experiences using the Laguna Thrombectomy System developed by Innova Vascular, Inc.

“These early cases highlight the excellent versatility the Laguna Thrombectomy System offers across a wide range of clot morphologies,” Dr. Arslan said. “This user-friendly solution, which integrates both clot retrieval and aspiration, represents an important tool for clinicians as they provide patients with the critical care they need.”

The Laguna Thrombectomy System,* which consists of the Malibu Aspiration Catheter System and the Laguna Clot Retriever System, received 510(k) clearance from the U.S. FDA in June 2023, and is designed to offer clinicians more flexibility to treat thromboembolism cases. Varian, a Siemens Healthineers company, announced an agreement earlier this year to be the exclusive U.S. distributor for the Laguna Thrombectomy System, underscoring its commitment to expanding access to new treatment options across cancer care and providing comprehensive, innovative tools for interventional therapies.

“Our collaboration with Innova Vascular exemplifies our commitment to advancing the critical field of venous thromboembolism (VTE) management, especially given its significant impact on cancer patients,” says Frank Facchini, MD, FSIR, President of Varian Interventional Solutions. “By integrating Varian’s interventional therapies with Siemens Healthineers’ advanced imaging solutions, we are at the forefront of shaping integrated care. This initiative aims to deliver more precise, effective, and accessible treatments that can significantly improve outcomes for the more than 1.2 million VTE cases that impact U.S. patients each year.”

VTE incidence among cancer patients is three-to-seven times higher than the overall population. Outside of cancer itself, thrombosis the leading cause of death among cancer patients, and complicates the care of cancer.

“By integrating Varian’s interventional therapies with Siemens Healthineers’ advanced imaging solutions, we are at the forefront of shaping integrated care. This initiative aims to deliver more precise, effective, and accessible treatments that can significantly improve outcomes for the more than 1.2 million VTE cases that impact U.S. patients each year.”
– Frank Facchini, MD, FSIR, President of Varian Interventional Solutions.

Designed for use in conjunction with the Malibu Aspiration Catheter System, the Laguna Clot Retriever System is a self-expanding clot retriever designed with a Nitinol structure that is delivered inside a sheath. The retriever head is designed with radiopaque body markers, which are intended to show the deployment of the Laguna Clot Retriever under image guidance. The Malibu Aspiration Catheter is designed to have increased flexibility, navigation and torquability through challenging anatomies, for increased control and optimum clot extraction.

The Malibu Aspiration Catheter System comes in a variety of sizes, which can be used in combination to navigate to clots in difficult to reach areas, Dr. Arslan shared. Additionally, he said, the catheter’s soft tip dilator minimizes damage to vessels, “so as you maneuver the catheter through complex areas, you don’t have to worry about traumatizing peripheral branches.”

Dr. Arslan, who served as an advisor to Innova in the development of the innovative system, shared cases by John M. Moriarty, MD, FSIR, David Geffen School of Medicine at UCLA, and S. Jay Mathews, MD, FACC, FSCAI, Manatee Memorial Hospital, that demonstrated the trackability and user-friendly design of the solution.

“It’s very clearly visualized under fluoroscopy,” Dr. Arslan said. “The Laguna Clot Retriever is easy to use … you just have to center it over the clot and then start aspiration, pulling the clot into the catheter.”

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Additionally, he shared, one advantage of the thrombectomy device observed in early cases has been the design of the clot retriever, which expands in, and around the clot, minimizing the risk of fragmentation. “The Laguna system is designed to capture the clot and keep it whole while aspiration is applied, pulling it through the Malibu aspiration catheter,” Dr. Arslan added. “That’s important for cases where the clot has been in the body longer and is more difficult to remove, or in cases where there is a large volume of clot that must be removed in relatively short period of time.”

With its combination of the Malibu Aspiration Catheter and the Laguna Clot Retriever, the Laguna system is designed to enable the removal of clots quickly, safely and in large volumes while managing blood loss during the procedure, something that had been difficult due to limitations in conventional clot extraction technology.

The Laguna Thrombectomy Solution by Innova Vascular Inc. is distributed exclusively in the US by Varian Medical Systems, Inc.

*FDA 510(k) cleared. The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.

The information captured herein represents the genuine experience of the attributed individuals and may not necessarily represent the views of Varian or the above referenced institutions. Individuals were not compensated for their participation.

  1. Lutsey PL, Zakai NA. Epidemiology and prevention of venous thromboembolism. Nat Rev Cardiol. 2023 Apr;20(4):248-262. doi: 10.1038/s41569-022-00787-6. Epub 2022 Oct 18. PMID: 36258120; PMCID: PMC9579604.
  2. Heloni M. Dave, MBBS and Alok A. Khorana, MD, FACP, FASCO. Management of venous thromboembolism in patients with active cancer. Cleveland Clinic Journal of Medicine February 2024, 91 (2) 109-117; DOI: https://doi.org/10.3949/ccjm.91a.23017
  3. Mahajan A, Brunson A, Adesina O, Keegan THM, Wun T. The incidence of cancer-associated thrombosis is increasing over time. Blood Adv. 2022 Jan 11;6(1):307-320. doi: 10.1182/bloodadvances.2021005590. PMID: 34649273; PMCID: PMC8753193.

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