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 studyThe 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 of 77.3%.
- The 12-month primary safety endpoint of 98.7% also exceeded the
corresponding performance goal of 89%.
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
57% of treatment plans compared to venography alone [4]. Led by
Philips, intravascular imaging is used in more than 70% of venous
stent procedures [5]. “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 ~25% of
Symptomatic DVD 2 Thrombosis: a major contributor to the
global disease burden. J Thromb Haemost 2014; 12:
1580–90. - Leveraged for DVT incidence in some countries (ex.
EU5) 3 DRG VTE Epidemiology Reports- Leveraged for DVT
incidence in some countries 4 Inari Medical presentation
and Khan, SR, Arch Intern Med 2004- Leveraged for assumption of
PTS.[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
MalthaPhilips Global Press OfficeTel. : +31 (6) 1055
8116Email : joost.maltha@philips.com
About Royal PhilipsRoyal 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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