Presentations and Publications
Tack Optimized Balloon Angioplasty: TOBA Trial 12 Month Results
(Presented by Dr. Marc Bosiers at LINC Conference 2015)
- Key conclusions from the TOBA study included:
- 89.5% freedom from clinically driven target lesion revascularization (CD-TLR) rate at 12 months. CD-TLR accounts for repeat procedures, or re-interventions, due to recurrent symptoms related to the treated lesion.
- 76.4% 12-month Kaplan-Meier patency rate. Patency means a sustained restoration of adequate blood flow was achieved through the treated segment of the diseased artery. Most of the subjects had significant dissections, which are graded from A to F. In the study, 74% of the patients had dissections graded C or higher, and less than 5% of the patients had simple Grade A dissections, based on independent core lab adjudication.
- 98.5% technical success rate.
- No evidence of migration or movement of Tack implants throughout the 12 month follow up period.
Link: Tack Optimized Balloon Angioplasty: TOBA Trial 12 months Results
First-In-Man Clinical Study Results Published
(Journal of the American College of Cardiology, April 2015)
- Successful dissection repair was achieved at all the lesion sites with the placement of the Tack implant, as determined by angiography. The key endpoints at 12 month follow up included:
- 100% repair of dissection flaps
- 12 month patency rates:
- 87.5% for SFA and Popliteal vessels
- 83.3% for SFA, Popliteal and Tibial vessels
- 80.0% for only Tibial vessels
- No limb loss
- No implant migration.
- One target lesion revascularization and death occurred, not related to the device or procedure
Link: American College of Cardiology: Cardiovascular Interventions