Intact Vascular Announces Presentation of TOBA II Pivotal Data
Data to be presented as a Late-Breaking Clinical Trial at the 2018 VIVA Conference
WAYNE, Pa.--(BUSINESS WIRE)-- Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that data from its Tack Optimized Balloon Angioplasty (TOBA) II pivotal clinical trial will be presented at the 15th Annual VIVA Conference in Las Vegas, NV on November 5-8.
The TOBA II trial is the first-of-its-kind designed to investigate the safety and efficacy of the Tack Endovascular System® for the repair of post-angioplasty dissections in femoropopliteal arteries. The Tack Endovascular System, a dissection repair device that is pre-loaded with 6 self-expanding nitinol devices for above-the-knee (ATK) interventions, can be deployed to treat multiple dissections using a single catheter and leave behind >70% less metal than stents.1 Patients with peripheral arterial disease (PAD) who are treated with balloon angioplasty often suffer from dissections or tears in the artery wall. Dissections can result in acute thrombosis and occlusions if left untreated, and can lead to recurrent or worsening symptoms and repeat procedures.
“The TOBA II data being presented at VIVA provide important clinical evidence regarding the therapeutic effectiveness of treating dissections with Tack® implants in a challenging patient population,” said Peter Schneider, MD, Vascular Surgeon at Kaiser Permanente in Honolulu, Hawaii, and Co-Founder and Chief Medical Officer of Intact Vascular. “Patients with peripheral arterial disease who are treated with balloon angioplasty and suffer dissections, or tears, in their artery wall are subject to increased risk of occlusions. We look forward to sharing the findings from the TOBA II trial, a first-of-its-kind pivotal trial studying the Tack Endovascular System in patients with 100% dissected vessels.”
Additional presentations of interest related to the Tack Endovascular System are listed below in Pacific Time and will take place at the Wynn Las Vegas.
Monday, November 5
1:15PM: When and How to Bail Out After POBA of the Tibial and Pedal Vessels: George Adams, MD
Tuesday, November 6
9:27AM: Late-Breaking Clinical Trial - TOBA II 12-month Pivotal Trial Results: William Gray, MD
4:00PM: Stent Technology Has Dramatically Improved Results in the Fem-Pop Segment: Review of Available and Upcoming Scaffolds: Saher Sabri, MD
Wednesday, November 7
2:15PM: Tack-Optimized Angioplasty: Its Role in BTK and Early Results: Marianne Brodmann, MD
Thursday, November 8
7:05AM: Post-Angioplasty Tibial Dissection Repair: Patrick Geraghty, MD
9:05AM: Comparative SFA Technologies, Self-Expanding Nitinol Scaffolds: William Gray, MD
9:10AM: Limb Salvage Pearls: Strategies for Optimizing Acute Results of BTK Intervention: Balloon Sizing, Best Minimal Lumen Diameter, Managing Dissections, and More: Francesco Liistro, MD
2:15PM: Assessment of Post-DCB Dissections: Deciding Which to Treat and How: Ehrin Armstrong, MD
For more information, visit the Intact Vascular booth #206 during VIVA.
Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack implant with both plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in the arteries above the knee. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. TOBA III, which has completed enrollment in Europe, is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.
Visit http://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease and critical limb ischemia.
About Intact Vascular
Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.
This press release contains “forward-looking statements” concerning the development of Intact Vascular's products, the therapeutic potential and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.
Bosiers M, Scheinert D, Hendriks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.
|CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.|
|The Tack Endovascular System is CE Mark Authorized under EC Directive 93/42/EEC.|
|The Tack Endovascular System is not approved for sale or use in the United States.|
|Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.|
|Lutonix® is a trademark of C.R. BARD, Inc.|
|IN.PACT(TM) Admiral(TM) are trademarks of Medtronic|
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
Source: Intact Vascular, Inc.