Philips launches Duo Venous Stent System for treatment of symptomatic venous outflow obstruction
Royal Philips (NYSE: PHG) announced the launch of the Duo Venous Stent System after obtaining premarket approval from the FDA. The system, designed to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), was first used outside clinical trials on June 12, 2024, at Sanger Heart & Vascular Institute, Atrium Health. The Duo Venous Stent System includes two stents, Duo Hybrid and Duo Extend, engineered to address the complexities of venous anatomy and obstructions.
The VIVID study, a global clinical trial, supported FDA approval by demonstrating a 90.2% primary patency rate and 98.7% safety rate at 12 months, exceeding performance targets. Improved quality of life and venous functional assessments were noted in patients. Philips' launch aims to enhance clinical outcomes and quality of life for CVI patients globally.
- FDA premarket approval for Duo Venous Stent System
- First successful implementation outside clinical trials on June 12, 2024
- 90.2% primary patency rate at 12 months, exceeding the target of 77.3%
- 98.7% safety rate at 12 months, exceeding the target of 89%
- Enhanced quality of life and venous functional assessments in patients
- Supports Philips' robust portfolio of medical technology
- No significant negative aspects reported in the press release
Insights
The launch of Philips' Duo Venous Stent System, following FDA premarket approval, represents a significant advancement in the treatment of symptomatic venous outflow obstruction. Chronic venous insufficiency (CVI) affects millions worldwide, often leading to severe discomfort and debilitation. The Duo Venous Stent System, designed with two stents that provide differential mechanical properties, addresses the specific anatomical challenges of venous disease. This innovation could improve clinical outcomes by reducing complications like stent fracture and corrosion, which are common with traditional stents. The VIVID study's results are particularly promising, showing higher than anticipated safety and efficacy metrics, with a 12-month primary patency rate of
For retail investors, these clinical results signal Philips' strong positioning in the vascular health market, potentially translating to increased market share and revenues in the long term.
This FDA approval and the subsequent launch of the Duo Venous Stent System by Philips mark a critical milestone for the company. From a financial perspective, this product launch could significantly boost Philips' revenue streams within its health technology portfolio. The addressable market for chronic venous insufficiency treatment is substantial, affecting millions globally. With the VIVID study indicating robust primary efficacy and safety results, this new device is likely to gain rapid adoption among healthcare providers. Also, Philips' integration of intravascular ultrasound (IVUS) with the Duo Stent System creates a compelling, differentiated offering that could draw additional market interest.
For investors, it's essential to consider both short-term stock volatility around the launch and long-term revenue growth driven by expanded market penetration and adoption. Given the positive clinical outcomes and Philips' established presence in health technology, this development bodes well for the company's financial outlook.
The Duo Venous Stent System's introduction underscores Philips' strategic focus on expanding its cardiovascular technology portfolio. The comprehensive results from the VIVID study, which show significant improvements in patients' quality of life and venous function scores, highlight the device's potential impact on the market. The dual-stent design addresses specific mechanical challenges that have long impeded effective CVI treatment, positioning Philips to capture a significant share of the venous stent market. Additionally, the mandated use of IVUS in the VIVID study, which led to better diagnostic accuracy and treatment outcomes, enhances the appeal of Philips' integrated solution to healthcare providers.
For retail investors, understanding the broader market implications is crucial. Philips' continued innovation and successful FDA approval of advanced medical devices could solidify its competitive edge, leading to better market performance and potentially higher stock valuation.
June 12, 2024
Sanger Heart & Vascular Institute, Atrium Health, treated the first patient with the new implantable medical device following FDA premarket approval
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the first implant of the Duo Venous Stent System, an implantable medical device indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), following premarket approval (PMA) from the U.S. Food and Drug Association (FDA).
On June 11, Dr Erin Murphy – vascular surgeon and director of the Venous and Lymphatic Program at the renowned Sanger Heart & Vascular Institute, Atrium Health, in Charlotte, N.C., and an investigator in the VIVID study, which contributed to the device’s FDA approval – successfully used the Duo Venous Stent System for the first time outside of a clinical trial.
Impacting 25 million people globally [1], deep venous disease results from venous thromboembolism, a condition that occurs when a blood clot forms in the vein [2]. It is the third most common cardiovascular disease [2]. Deep venous anatomy and obstructions can present a multitude of complexities and mechanical challenges.
Engineered for the unique demands of venous anatomy and obstructions, the Duo Venous Stent System is comprised of two stents – Duo Hybrid and Duo Extend – of various sizes. Duo Hybrid has a distinct integrated design that combines multiple zones of differing mechanical properties into a single stent [3]. For long lesions, Duo Extend smoothly overlaps with the Duo Hybrid to extend therapy. These two stents are designed to work together and minimize the risk of stent fracture and corrosion, while providing an option to stent within caudal veins with smaller diameters [3].
“Duo is the first stent that offers a differential design for the challenges of venous anatomy – a focal area that withstands the forces of compression as well as the flexibility to accommodate curvature of the vessel,” said Dr Kush Desai, a highly regarded Interventional radiologist and associate professor of Radiology, Surgery and Medicine at Northwestern University in Chicago, as well as a leading enroller and investigator for the VIVID study.
“Consequently, Philips is well positioned to support CVI treatment by offering a robust portfolio of medical technology that includes both intravascular ultrasound and a differentiated venous stenting system.”
VIVID study
The VIVID study is a global, prospective, multi-center, single-arm, non-blinded clinical trial conducted in the U.S. and Poland, evaluating the safety and efficacy of the Philips Duo Venous Stent System in the treatment of nonmalignant iliofemoral occlusive disease. It enrolled 162 subjects at 30 centers with three patient populations – non-thrombotic iliac vein lesion (NIVL), post-thrombotic syndrome (PTS) and acute deep vein thrombosis (aDVT). The VIVID study is now in 36-month follow-up and upon FDA PMA approval transitioned from an investigational device exemption (IDE) study to a post-approval study (PAS): NCT04580160.
The VIVID study met all of its primary safety and efficacy performance goals.
- The 12-month effectiveness endpoint for primary patency reached
90.2% , which exceeded the performance target goal of77.3% . - The 12-month primary safety endpoint of
98.7% also exceeded the corresponding performance goal of89% .
In addition, quality of life and venous functional assessments that were performed in the VIVID study – including Clinical-Etiology-Anatomy-Pathophysiology (CEAP), Venous Clinical Severity Score (VCSS), Villalta, EQ-5D-3L and VEINES scores – showed sustained improvements compared to baseline at 12 months.
“The VIVID study’s 12-month results demonstrate the safety and efficacy of the Duo Venous Stent System in the treatment of chronic venous insufficiency, a vascular condition affecting millions of people worldwide,” said principal investigator Dr Mahmood Razavi, M.D., an interventional radiologist with St. Joseph Vascular in Orange County, Calif.
“Duo represents a meaningful addition to the tools that clinicians can use to treat CVI patients,” Dr Razavi added, “especially when used in conjunction with intravascular ultrasound, or IVUS. Ultimately, the new device promises to enable excellent clinical outcomes and drive significant quality of life improvements.”
The VIVID study was the first clinical trial to mandate IVUS use to aid in lesion assessment and stent sizing prior to device implantation. According to prior published research, IVUS supports accurate diagnosis of venous disease and has been shown to change
“The launch of the Duo Venous Stent System represents another step forward in achieving our aspiration to innovate interventional procedures with advanced medical technology,” said Heather Hudnut Page, Vice President and Business Leader of Peripheral Vascular at Philips. “In this context, we look forward to bringing the combined offering of intravascular ultrasound and Duo to the interdisciplinary teams – from vascular surgeons to interventional radiologists and interventional cardiologists – who share our overarching goal of enhancing patient care.”
[1] Market Model Sources- DVD: 1 US Physician Quant Survey- Leveraged for NIVL prevalence assumption as ~
[2] Scheres LJJ, Lijfering WM, Cannegieter SC. Current and future burden of venous thrombosis: Not simply predictable. Res Pract Thromb Haemost. 2018 Apr 17;2(2):199-208. doi: 10.1002/rth2.12101. PMID: 30046722; PMCID: PMC6055567.
[3] Data on file: D062749
[4] Gagne PJ, Tahara RW, Fastabend CP, et al. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction. J Vasc Surg Venous Lymphat Disord. 2017;5:678-687.
[5] Divakaran S, Meissner MH, Kohi MP, et al. Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries. J Vasc Interv Radiol. 2022;33(12):1476-1484.e2. doi:10.1016/j.jvir.2022.08.018
Regulatory disclosures
Developed by Vesper Medical, Inc., a wholly owned subsidiary of Philips, the Duo Venous Stent System is being marketed under the Philips brand. Its FDA approval order, along with related regulatory information, can be found here: PMA approval for Duo Venous Stent System.
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
For further information, please contact:
Joost Maltha
Philips Global Press Office
Tel. : +31 (6) 1055 8116
Email : joost.maltha@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.
Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,100 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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