PURPOSE–BUILT. PRECISION REPAIR. PRESERVES OPTIONS.
Infrapopliteal dissection repair using the
Tack Endovascular System (4F,1.5-4.5mm)
following plain balloon angioplasty (POBA)
30d Freedom from MALE + POD*
Freedom from 6m MALE + 30d POD*
6m K-M Target Limb Salvage**
6m K-M Tacked Segment Patency+
Sustained Patient and Clinical Outcomes with No Implant Fracture,
Migration or Embolization at 12 months
12m K-M Tacked Segment Patency+,†
12m K-M Freedom from CD-TLR†
12m K-M Target Limb Salvage in CLI Patients (RC 4/5)‡
12m K-M Amputation-Free Survival in CLI Patients (RC 4/5)‡
of Patients Improved to RC≤2 at 12 months‡
TOBA II BTK 12-month results confirm that the Tack Endovascular System (4F, 1.5-4.5mm) is a durable, below-the-knee implant for post-PTA dissection repair that optimizes angioplasty to save limbs.
STATUS: This study has met its primary endpoints, and patients are in follow-up phase.
DESCRIPTION: TOBA II BTK is a multi-center, global pivotal study and the first IDE clinical trial approved in the United States to investigate the safety and effectiveness of a permanent vascular implant as a treatment for postangioplasty dissections in arteries below the knee (BTK). TOBA II BTK evaluates the Tack Endovascular System (4F, 1.5-4.5mm) in patients with critical limb ischemia (CLI) and dissections resulting from percutaneous transluminal angioplasty (PTA) using a standard balloon in the mid/distal popliteal, tibial and peroneal arteries.
There were a total of 233 subjects enrolled at 41 sites in US, Europe and New Zealand.
Six-month results were presented in Las Vegas, Nevada at the 2019 VIVA Conference by Dr. George Adams.
Twelve-month results were presented at the 2020 VIVA Late Breaking Clinical Trials Livestream by Dr. Patrick Geraghty.
* MALE + POD: composite of all-cause death, above-ankle target limb amputation, or major re-intervention to the target lesion(s), defined as new bypass graft, Jump/interposition graft revision, or thrombectomy/thrombolysis.
**Target Limb Salvage: freedom from above-ankle target limb amputation.
+DUS flow or no flow at 6m; TACKED SEGMENT: Tack implant + 5mm of artery proximal and distal; Tacks within 1cm areconsidered same segment.
†12 month data has not been reviewed by FDA.
‡Post-hoc analysis, has not been reviewed by FDA.