TOBA-II-BTK

Infrapopliteal dissection repair using the
Tack Endovascular System (4F,1.5-4.5mm)
following plain balloon angioplasty (POBA)

ENDPOINTS (N=233)

SAFETY

98.7%

30d Freedom from MALE + POD*

95.6%

Freedom from 6m MALE + 30d POD*

EFFICACY

98.6%

6m K-M Target Limb Salvage**

87.7%

6m K-M Tacked Segment Patency+

Sustained Patient and Clinical Outcomes with No Implant Fracture,
Migration or Embolization at 12 months

100%

Dissections Resolved

81.3%

12m K-M Tacked Segment Patency+,†

83.1%

12m K-M Freedom from CD-TLR

96.1%

12m K-M Target Limb Salvage in CLI Patients (RC 4/5)

89.0%

12m K-M Amputation-Free Survival in CLI Patients (RC 4/5)

79.1%

of Patients Improved to RC≤2 at 12 months

Conclusion:

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.

To learn more about this study, visit www.clinicaltrials.gov and search for NCT02942966.

* 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.

PURPOSEBUILT. PRECISION REPAIR. PRESERVES OPTIONS.

Scroll to Top
Intact Vascular uses cookies to improve your experience on this website. Some of the cookies we use are essential for parts of the website to operate. Please be aware that if you continue without changing your cookie settings, you consent to this.