Two-year data from the TOBA II BTK clinical trial demonstrate durability of dissection repair below the knee with the Philips Tack Endovascular System
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)
MD, Interventional Cardiologist at Rex Hospital
“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.
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