Intact Vascular Sponsors Symposium on Post-Angioplasty Dissections Post-PTA dissection: clinical impact, identification and treatment

May 29, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the schedule of key presentations that will be featured during a symposium sponsored together with Philips at the 19th Annual NCVH Conference in New Orleans on May 31.

Post-Percutaneous Transluminal Angioplasty (“PTA”) dissections are often overlooked, underdiagnosed and left untreated. These dissections can compromise clinical outcomes in both the short and long term. The use of intravascular ultrasound (“IVUS”) helps visualize the presence and severity of dissections not seen on angiography.

The Tack Endovascular System® is a new solution for precision dissection repair following balloon angioplasty with a first-of-its-kind implant that is designed to help maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. The Tack Endovascular System leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options.

The co-sponsored symposium titled, “Post-PTA dissection: clinical impact, identification and treatment” will feature Ehrin Armstrong, MD, Nicolas Shammas, MD and George Adams, MD, and will include the following presentations:

  • Dissections matter: Evidence for post-PTA dissection, Ehrin Armstrong, MD
  • Dissection identification and classification using IVUS: The iDissection grading system, Nicolas Shammas, MD
  • Dissection repair with the Tack Endovascular System: Trial data, George Adams, MD

Notably, the iDissection identification and classification using IVUS presentation by Nicolas Shammas, MD will feature the recently completed study results from his iDissection pilot study. In the pilot study, 15 patients with femoropopliteal disease were treated with atherectomy and adjunctive PTA. Angiographic and IVUS images were obtained at baseline, post-atherectomy and post-angioplasty utlizing Philips ChromaFlo Imaging and evaluated for the presence and severity of dissections.

“Our mission at Intact Vascular is to make all forms of angioplasty more effective and durable. Identification of dissections and appropriate treatment is critical to maximize long term clinical success,” said Bruce Shook, Intact Vascular’s President and CEO. “We want to thank Philips for being a co-sponsor at NCVH to highlight the importance of IVUS to properly diagnose dissections often missed when using conventional angiography.”

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, and completed enrollment in March 2017. 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 has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.

Visit https://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 potential benefits 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.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM) are trademarks of Medtronic, Inc.
“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.
Not available for sale or use in the United States.