October 8, 2018 – 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.
July 11, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today welcomed the publication of the iDissection Classification trial results in the current issue of Journal of Invasive Cardiology.
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) has been found to help visualize the presence and severity of dissections not typically seen on angiography.
In the iDissection study, 15 patients with femoropopliteal disease were treated with atherectomy and adjunctive PTA. Angiographic and IVUS images utilizing ChromaFlo Imaging (Philips) were obtained at baseline, post-atherectomy and post-angioplasty and evaluated for the presence and severity of dissections. Dissections seen on angiography were graded per the NHLBI scale, and IVUS images were graded using the iDissection classification. All images were independently adjudicated by multiple core laboratories. While angiography identified 8 dissections, IVUS revealed 46 dissections—a ratio of 6:1. The iDissection study reveals that significant dissections may not be thoroughly observed with angiography yet are substantially more visible when using IVUS, potentially altering the course of patient treatment in real-time.
“Angiography is a suboptimal test to visualize the peripheral arteries. It underestimates vessel size, the presence and extent of calcium, thrombus and stenosis, and does not give a clear picture of optimal stent expansion and apposition. Moreover, the iDissection data confirms that angiography seriously underestimates the presence and severity of dissections following endovascular intervention,” commented Dr. Nicolas W. Shammas, Founder and Research Director, Midwest Cardiovascular Research Foundation, Davenport, Iowa. “The iDissection study validates the need for more sophisticated imaging, such as IVUS, to evaluate acute procedural results.”
“We are very pleased with the results from the iDissection study and the expanding evidence incorporating IVUS as a useful tool to identify dissections often missed when using conventional angiography,” said Bruce Shook, Intact Vascular’s President and CEO. “The Tack Endovascular System® is specifically designed to repair dissections while leaving minimal metal in the artery, thereby reducing mechanical stress on the arterial wall and preserving future treatment options.”
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.
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.
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.
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