TOBA II BTK

Femoropopliteal 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+

CLINICAL OUTCOMES

100%

Dissections Resolved

87.3%

6m K-M Target Lesion Patency

92.0%

6m K-M Freedom from CD-TLR

PATIENT OUTCOMES

73.8%

Wounds Healed or Improved at 6 months

74.0%

of CLI Patients Decreased to RC ≤3 at 6 months

92.0%

6m K-M Amputation-Free Survival

Conclusion:

High rates of dissection resolution, wound healing, target limb salvage and freedom from CD-TLR support the Tack Endovascular System (4F, 1.5-4.5mm) as an ideal adjunct to angioplasty.

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 VIVA 2019 Conference by Dr. George Adams.

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.

TARGET LESION PATENCY: DUS flow or no flow in PTA treated length.

PURPOSEBUILT. PRECISION REPAIR. PRESERVES OPTIONS.

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