Philips announces positive three-year clinical research results from its Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial
13 Juni 2022 - 3:00PM
Philips announces positive three-year clinical research results
from its Tack Optimized Balloon Angioplasty (TOBA) II
below-the-knee (BTK) clinical trial
June 13, 2022
- For below-the-knee arterial dissection repair following balloon
angioplasty, innovative medical technology shows sustained
treatment effect and positive impact on quality of life for
patients with critical limb ischemia (CLI)
- First and only FDA-approved device of its kind demonstrates
consistently high rates of target limb salvage (93.9%) and freedom
from clinically-driven target lesion revascularization (69.6%)
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced the latest results from the Tack Optimized Balloon
Angioplasty (TOBA) II below-the-knee (BTK) clinical trial,
demonstrating that the Philips endovascular system – Tack (4F) –
the first and only device of its kind approved by the U.S. Food and
Drug Administration (FDA), provides a sustained treatment effect
and positive impact on quality of life for patients with critical
limb ischemia (CLI), a severe stage of peripheral arterial disease
(PAD), out to three years of clinical follow-up.
CLI occurs when an obstruction in an artery severely reduces
blood flow, causing painful wounds, debilitating rest pain,
recurring ulcers and life-threatening infection. If left untreated,
50% of patients with CLI will undergo an amputation or die within
the first year [1].
The TOBA II BTK trial studied the safety and efficacy of
post-angioplasty dissection repair using the Philips Tack
endovascular system in patients with CLI and infrapopliteal
disease. The Tack endovascular system is a unique specialized
implantable device to optimize the treatment of dissections in
patients with CLI. Endpoints included rates of major adverse
events, target lesion revascularization (TLR), target limb salvage
(TLS) and quality of life (QoL) metrics.
“Based on 36-month follow-up in the TOBA II BTK trial, which is
following 233 patients at 41 sites internationally, the Tack
endovascular system offers a new standard in repairing
below-the-knee arterial dissections,” said co-principal
investigator George Adams, M.D., director of cardiovascular and
peripheral vascular research at UNC Rex Hospital in Raleigh, N.C.,
and clinical associate professor of medicine at the University of
North Carolina at Chapel Hill, who presented the results to
hundreds of interventional cardiologists, interventional
radiologists and vascular surgeons at the New Cardiovascular
Horizons (NCVH) conference in New Orleans, USA, on June 2.
Adams added: “The device stands to significantly benefit
patients with CLI whose treatment with balloon angioplasty often
leads to this particular complication, which typically goes
untreated and unaddressed, to the detriment of long-term clinical
outcomes.”
The three-year analysis of TOBA II BTK results includes the
following clinical insights on the Tack endovascular system:
- 93.9% target limb salvage in CLI patients at three years
- 69.6% freedom from clinically-driven target lesion
revascularization across all patients at three years
- Sustained improvement in established clinical classification
systems including the Rutherford clinical category and hemodynamics
in ankle- and toe-brachial indices
- Sustained improvement in patient-reported quality-of-life and
mobility measures
“In treating peripheral arterial disease below the knee with
balloon angioplasty, dissections of the popliteal, tibial and
peroneal arteries occur with considerable frequency,” explained
Chris Landon, business leader of Image Guided Therapy Devices at
Philips. “With the Tack endovascular system from Philips,
interventionists can reliably repair below-the-knee arterial
dissections – and in doing so, improve major amputation rates and
quality of life.”
Philips has previously reported data from the TOBA II and III
studies, which evaluated the Tack endovascular system for
superficial femoral and proximal popliteal artery dissection repair
following uncoated balloon angioplasty and/or drug-coated balloon
(DCB) angioplasty. These multicenter, global and European studies
demonstrated that the use of the Tack endovascular system resulted
in overwhelming dissection resolution following uncoated or DCB
angioplasty.
- In TOBA II, which involved uncoated and drug-coated balloons,
dissection repair with the Tack System resulted in 89.6% and 86.5%
12-month primary patency (uncoated balloon group) and freedom from
CD-TLR
- In TOBA III, which involved drug-coated balloons, dissection
repair with the Tack endovascular system resulted in 95.0% and
97.5% 12-month primary patency and freedom from CD-TLR
There were no major adverse events reported through 30 days in
either study.
Together, the TOBA II, TOBA III and TOBA II BTK trials support
the safety and efficacy of the Tack endovascular system for
post-PTA dissection repair in above- and below-the-knee arterial
disease. The 36-month TOBA II BTK data reported at NCVH adds to the
robust body of clinical evidence supporting the safety and
effectiveness of the Tack Endovascular System in both vessel
beds.
Philips Tack endovascular system is currently available for sale
in the USA and some EU countries. Further information, including
safety information, is available here. The system is part of the
company’s peripheral vascular portfolio, which includes advanced
interventional imaging systems for precision guidance including
Vascular Suite on its Image Guided Therapy System – Azurion;
intravascular ultrasound (IVUS) catheters to assess the location of
the disease and lesion morphology and guide and confirm the
treatment; peripheral atherectomy devices to remove blockages;
sculpting balloons to prep the vessel; and peripheral therapy
devices, such as Philips’ Stellarex drug-coated balloon, to treat
lesions.
[1] Hirsh AT, Jaskal ZJ, Hertzer, et al. ACC/AHA 2005 guidelines
for the management of patients with peripheral arterial disease
(lower extremity, renal, mesenteric, and abdominal aortic):
executive summary a collaborative report from the American
Association for Vascular Surgery/Society for Vascular Surgery,
Society for Cardiovascular Angiography and Interventions, Society
for Vascular Medicine and Biology, Society of Interventional
Radiology, and the ACC/AHA Task Force on Practice Guidelines
(Writing Committee to Develop Guidelines for the Management of
Patients With Peripheral Arterial Disease) endorsed by the American
Association of Cardiovascular and Pulmonary Rehabilitation;
National Heart, Lung, and Blood Institute; Society for Vascular
Nursing; TransAtlantic Inter-Society Consensus; and Vascular
Disease Foundation. J Am Coll Cardiol. 2006 Mar
21;113(11):e463-654.
For further information, please contact:
Joost Maltha Philips Global Press Office Tel:
+31 610 558
116 E-mail: joost.maltha@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: + 31 622
698 001E-mail: fabienne.van.der.feer@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, and enabling better outcomes across the health
continuum – from healthy living and prevention, to diagnosis,
treatment and home care. Philips leverages advanced technology and
deep clinical and consumer insights to deliver integrated
solutions. Headquartered in the Netherlands, the company is a
leader in diagnostic imaging, image-guided therapy, patient
monitoring and health informatics, as well as in consumer health
and home care. Philips generated 2021 sales of EUR 17.2 billion and
employs approximately 79,000 employees with sales and services in
more than 100 countries. News about Philips can be found at
www.philips.com/newscenter.
- Philips Tack Endovascular System (4F) - 1
- Philips Tack Endovascular System (4F) - 2
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