InterVene Reaches Key Milestone with 30 Procedures Using Recana Thrombectomy System
InterVene, Inc., a privately held medical device company focused on advancing interventional solutions for venous disease, has announced a significant clinical milestone: the successful completion of 30 procedures using its Recana® Thrombectomy Catheter System. These initial cases were conducted as part of the company’s limited market release in the United States, along with its first-in-human clinical study in Europe.
This achievement represents an important step forward for the company as it moves closer to a broader commercial rollout of its innovative technology, which is designed to address complex and often treatment-resistant venous conditions.
Addressing Complex and Treatment-Resistant Cases
The first 30 cases treated with the Recana system included patients suffering from in-stent restenosis (ISR) as well as native vessel obstructions. Notably, many of these individuals had previously undergone multiple unsuccessful treatment attempts, highlighting the complexity and severity of their conditions.
In-stent restenosis occurs when a previously placed stent in a vein becomes narrowed or blocked again due to tissue growth or clot-related changes. Similarly, native vessel obstructions involve blockages in veins that have not been treated with stents but have become compromised due to chronic clotting or structural changes. Both conditions can be difficult to treat with conventional therapies, especially when prior interventions have failed.
The inclusion of such challenging cases in the initial cohort underscores the potential of the Recana system to address unmet clinical needs in venous disease management.
A First-of-Its-Kind Mechanical Thrombectomy System
The Recana® Thrombectomy Catheter System stands out as the first fully integrated mechanical thrombectomy device to receive U.S. FDA 510(k) clearance specifically for the treatment of venous in-stent restenosis and residual obstructions in native veins.
The system has been engineered with a comprehensive, purpose-built design that includes:
- A stainless steel helical debulking catheter for removing obstructive material
- Material collection baskets to capture debris during the procedure
- Introducer and collection sheaths that streamline device delivery and retrieval
Together, these components aim to simplify complex venous interventions while improving procedural efficiency and patient outcomes. By offering a fully integrated solution, Recana reduces the need for multiple tools and techniques, which are often required in traditional approaches.
Understanding the Burden of Venous Disease
Venous obstructions, whether due to ISR or native vessel disease, are often the result of chronic changes in blood clots. Over time, clots can become more fibrotic and resistant to standard treatments such as anticoagulation or thrombolysis. As these obstructions worsen, they narrow the vein’s lumen, impairing blood flow from the lower extremities.
This impaired outflow leads to venous hypertension, a condition associated with a range of symptoms, including:
- Persistent leg swelling
- Aching or heaviness in the limbs
- Skin discoloration
- Development of venous leg ulcers in severe cases
Chronic venous insufficiency (CVI), often caused by obstruction, reflux, or both, affects more than 25 million adults in the United States alone. Despite its prevalence, treatment options for advanced or treatment-resistant cases remain limited, leaving many patients with ongoing symptoms and reduced quality of life.
Physician Perspectives on Recana’s Impact
Clinicians involved in the early use of the Recana system have expressed optimism about its potential to transform how complex venous diseases are managed.
Professor Stephen Black, MD, a vascular surgeon based in London, emphasized the challenges associated with in-stent restenosis and the limitations of current treatment options. He noted that many patients experience significant discomfort and disability but are often managed conservatively due to a lack of effective interventions.
According to Dr. Black, his experience with the Recana system has “fundamentally changed” his approach to treating ISR, suggesting that the device may offer a more effective and proactive solution for these patients.
Similarly, Dr. Mark Garcia, an interventional radiologist in Wilmington, Delaware, highlighted the broader implications of the technology. He pointed out that millions of patients suffer from symptoms related to residual venous obstructions and that Recana shows promise as a new therapeutic option for addressing these conditions in native veins.
Limited Market Release and Ongoing Clinical Studies
InterVene is currently continuing its limited U.S. market release, working closely with a select group of physicians who specialize in treating ISR and complex venous obstructions. This phased approach allows the company to gather real-world clinical data, refine procedural techniques, and ensure optimal outcomes before expanding access more broadly.
In parallel, the company is sponsoring prospective clinical studies in Europe, further evaluating the safety and effectiveness of the Recana system. These studies are being conducted at leading institutions, including:
- Galway, Ireland, under the leadership of Dr. Gerry O’Sullivan
- London, England, led by Professor Stephen Black
These international efforts are expected to generate valuable clinical evidence to support the system’s adoption and inform best practices for its use.
Leadership Perspective and Future Plans
Jeff Elkins, Chief Executive Officer of InterVene, expressed gratitude to the physicians who collaborated with the company to reach this milestone. He acknowledged their expertise and commitment as critical factors in advancing the development and early adoption of the Recana system.
Elkins emphasized that the company remains focused on delivering purpose-built innovation for patients with difficult-to-treat venous conditions. He also noted that the completion of the first 30 cases marks an important step toward achieving broader clinical impact.
Looking ahead, InterVene plans to expand its commercial footprint later this year, building on the insights gained from its limited market release and ongoing studies. The company aims to make the Recana system more widely available to physicians and patients, potentially improving outcomes for those who have historically had limited treatment options.
A Step Forward in Venous Intervention
The successful completion of 30 procedures using the Recana® Thrombectomy Catheter System represents more than just a numerical milestone—it signals a potential shift in how complex venous obstructions are treated.
By targeting conditions that are often resistant to traditional therapies and offering a fully integrated mechanical solution, Recana may help bridge a longstanding gap in venous care. As InterVene continues to expand its clinical and commercial efforts, the system could play a significant role in improving quality of life for millions of patients affected by chronic venous disease.
With further validation from ongoing studies and increased adoption among specialists, the Recana system is poised to become an important tool in the evolving landscape of interventional venous therapy.
About the Recana® Thrombectomy Catheter System
Recana is the first fully integrated system cleared by the FDA for the treatment of venous in-stent restenosis (ISR) and residual native vessel obstructions. The system consists of a stainless steel helical debulking catheter, material collection baskets, and introducer and collection sheaths. Recana is a purpose-built, standalone platform designed to simplify complex venous procedures and improve clinical outcomes.
About InterVene, Inc.
InterVene is a privately held medical technology company based in Redwood City, California. The company is focused on developing transformative products to treat the long-term complications of venous disease. Its flagship technology, the Recana® Thrombectomy Catheter System, is designed to treat venous in-stent restenosis and residual vein obstructions and occlusions, life-altering conditions that affect millions of people globally. InterVene is backed by RiverVest Venture Partners and Treo Ventures
