Two-year data from the TOBA II BTK clinical trial demonstrate durability of dissection repair below the knee with the Philips...
04 June 2021 - 4:40AM
June 3, 2021
Results show that first-of-its-kind device has a sustained
treatment effect and a positive impact on quality of life
Amsterdam, the Netherlands – Royal Philips
(NYSE: PHG, AEX: PHIA), a global leader in health technology, today
announced positive two-year results from the Tack Optimized Balloon
Angioplasty (TOBA) II below-the-knee (BTK) clinical trial. The data
show the Philips Tack Endovascular System (4F), a first-of-its kind
dissection repair device, provides a sustained treatment effect and
positive impact on quality of life for Peripheral Artery Disease
(PAD) and Critical Limb Ischemia (CLI) patients at two years. The
data was presented by Co-Principal Investigator George Adams, MD,
Interventional Cardiologist at Rex Hospital affiliated with the
University of North Carolina at Chapel Hill, at the 2021 New
Cardiovascular Horizons (NCVH) conference (June 1-4).
Across all patients in the TOBA II BTK clinical trial at two
years, 73.6% had freedom from clinically driven target lesion
revascularization (CD-TLR) and did not require a repeat procedure
for the treated artery segment. CD-TLR is a commonly used indicator
of treatment efficacy durability. In the more complex CLI patient
population, which is typically associated with high rates of
amputation and mortality, the data showed 94.7% target limb salvage
(freedom from major amputation).
“The global endovascular community is diligently working to
better understand how to restore blood flow in small limb vessels,
promote healing and ultimately preserve limbs for people with CLI,
one of the most vulnerable and critical patient populations,” said
Dr. Adams. “These positive two-year data reiterate the clinical
importance of below-the-knee dissection repair and validates the
sustained durability of Tack-optimized interventions.”
The Tack Endovascular System is a unique specialized implantable
device to optimize the treatment of dissections in patients with
PAD and its more advanced stage, CLI. 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 two-year TOBA II BTK data also show sustained improvement in
patients’ quality of life. In a patient questionnaire that assesses
activity, pain and overall health, patients report having more
control of their health and increased improvement in mobility.
“This new data further demonstrates the value of the Tack
Endovascular System for repairing dissections and optimizing
post-angioplasty outcomes in a challenging patient population,”
said Chris Landon, Senior Vice President and General Manager, Image
Guided Therapy Devices at Philips. “Dissection repair following
balloon angioplasty has a positive, long-term value for both
clinicians and patients alike. The implant is an important part of
our complete procedural solutions to improve existing procedures
and expand treatment options for PAD and CLI patients.”
The Tack Endovascular System is a first-of-its kind dissection
repair device that is purpose-built to provide precision treatment
of peripheral arterial dissections following balloon angioplasty in
either above- or below-the-knee therapeutic interventions. The
minimal-metal implant is designed to minimize vessel inflammation,
promote healing, improve outcomes, preserve future treatment
options for PAD and CLI patients and – ultimately – limbs. The Tack
Endovascular System (4F) is the only vascular implant to receive
U.S. Food and Drug (FDA) pre-market approval for BTK interventions,
and TOBA II BTK is the first BTK investigational device exemption
(IDE) study to enroll 100% dissected vessels.
The Tack Endovascular System is the most recent addition to
Philips’ market-leading 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; and peripheral therapy devices, such as Philips’
drug-coated balloon – Stellarex – to treat lesions.
The Tack Endovascular System is currently available for sale in
the U.S. and some EU countries. Further information, including
safety information, is available here.
[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:
Mark GrovesPhilips Global Press OfficeTel: +31 631 639
916E-mail: mark.groves@philips.com
Fabienne van der FeerPhilips Image Guided TherapyTel: + 31 622
698 001E-mail: fabienne.van.der.feer@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, 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 2020
sales of EUR 17.3 billion and employs approximately 77,000
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
- Philips Tack Endovascular System 4F img 2
Koninklijke Philips NV (NYSE:PHG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Koninklijke Philips NV (NYSE:PHG)
Historical Stock Chart
From Apr 2023 to Apr 2024