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Intact Vascular to Announce One-Year Data from TOBA III Clinical Trial

By | 2019 Press Releases, Press Releases

Study Investigates Use of the Tack Endovascular System® for Focal Dissection Repair Following Drug-Coated Balloon Angioplasty in PAD Patients

September 16, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the one-year data from its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial will be presented during the High Impact Clinical Research session of the 31st Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiovascular Research Foundation.

Conducted in Europe, this multi-center, single-arm, prospective study investigates the combination of the Tack Endovascular System with the market leading drug-coated balloon, Medtronic’s IN.PACTAdmiralDCB, as a treatment in the superficial femoral (SFA) and/or proximal popliteal (PPA) arteries. The study enrolled 201 patients, all suffering from peripheral arterial disease (PAD) and includes a subset with long arterial lesions.

“The TOBA III data being presented at this year’s TCT meeting augments the already robust clinical evidence supporting the use of Tack implants to treat post-angioplasty dissections,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “We look forward to sharing the findings of the TOBA III trial and further demonstrating the impact this new, minimal metal therapeutic paradigm offers for patients suffering from peripheral arterial disease.”

Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University of Graz, Austria and Principal Investigator of the TOBA III trial, will present the one-year data on Friday, September 27th at 2:30 pm PST in the Innovation & Keynote Theater at the Moscone Center in San Francisco, California.

Additionally, Dr. Ehrin Armstrong, Director of Interventional Cardiology at the Rocky Mountain Regional VA Medical Center in Denver, Colorado, will present Clinical Trial Updates: BTK Tacks Scaffolds and Drugs during the Revascularization Strategies in CLI – State of the Art session during the TCT Endovascular: An Alliance Partner with the VEITHsymposium, on Wednesday, September 25th at 11:01 am PST in Room 156/158.

About Intact Vascular and the Tack Endovascular System

Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to repair dissections following peripheral balloon angioplasty. Pre-loaded with six self-expanding nitinol implants for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents.1 Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for peripheral arterial disease patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BD Interventional Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK has completed its primary endpoint analysis and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee. TOBA III has completed its primary endpoint analysis and is investigating the combination of the Tack implant with the Medtronic IN.PACT Admiral (DCB), with a long lesion subset.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the 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

1Bosiers M, Scheinert D, Hendricks 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.

Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of BD Interventional.
IN.PACT and Admiral are trademarks of Medtronic, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
“Tack Endovascular System (6F) FDA approved for use in the superficial femoral and proximal popliteal arteries, ranging from 3.5mm to 6.0mm RVD, for treatment of post-PTA dissections.”
“Tack Endovascular System (4F) CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”

Intact Vascular Announces $25 Million Financing with Vensana Capital to Drive Commercialization of the Tack Endovascular System®

By | 2019 Press Releases, Press Releases

May 29, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced a $25 million financing with Vensana Capital as the lead investor.  Vensana was joined by existing investors including New Enterprise Associates (“NEA”), H.I.G. BioHealth Partners, and Quaker Partners.  The Company reported closure of the initial tranche of the financing, with the remainder scheduled for draw down in 2020 as the Company ramps its commercialization of the Tack Endovascular System. 

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Intact Vascular to Sponsor Post-Angioplasty Dissection Symposium at 2019 New Cardiovascular Horizons Conference

By | 2019 Press Releases, Press Releases

May 20, 2019 – 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 to be featured during a lunch symposium at the 2019 New Cardiovascular Horizons (NCVH) Conference, May 29th through 31st at The Roosevelt New Orleans in New Orleans, Louisiana.

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Intact Vascular Announces Presentations at LINC 2019 Annual Meeting

By | 2018 Press Releases, Press Releases

Presentations Showcase the Importance of Treating Post-Angioplasty Dissections

January 14, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced the schedule of key presentations to be featured at the annual Leipzig Interventional Course (LINC) in Leipzig, Germany on Tuesday, January 22nd and Wednesday, January 23rd.

Intact Vascular’s Tack Endovascular System® is a first-of-its-kind dissection repair device implanted following post-angioplasty dissections in patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI). Patients often suffer from dissections that are frequently overlooked, undiagnosed and untreated. If untreated, these dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.

“We are pleased that the topic of post-angioplasty dissections is prominently highlighted this year at the LINC meeting,” stated Bruce Shook, President and CEO of Intact Vascular. “We are excited to share the robust clinical program for Intact’s Tack Endovascular System and demonstrate how our technology improves outcomes for patients.”

The following sessions will be presented on Tuesday, January 22nd:

1:00 – 1:05 (Main Arena – Room 1): TOBA II Trial: 1-Year Results, presented by William Gray, MD

1:35 – 1:40 (Technical Forum – Room 3): Dissecting the TOBA Data: What Does it Mean in Practice, presented by Peter Schneider, MD

Additionally, the following sessions will be presented on Wednesday, January 23rd in the Global Expert Exchange Forum (Room 5):

11:20 – 11:25: Dissections Matter: Evidence for Post-PTA Dissections, presented by Ehrin Armstrong, MD

11:25 – 11:30: Dissection Identification and Classification Using IVUS, presented by Nicolas Shammas, MD

11:30 – 11:35: How I Will Use the Tack Endovascular System® in the Real World, presented by Michael Lichtenberg, MD

Visit the Intact Vascular booth, #41, to learn more about the Tack Endovascular System.

About Intact Vascular and the Tack Endovascular System

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. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has recently completed enrollment. 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.

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

“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
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.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.

Intact Vascular Announces Launch of the Tack Endovascular System® in the EU and First Commercial Use in Germany

By | 2018 Press Releases, Press Releases

January 7, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System® in multiple hospitals within Germany. A novel therapy for dissection repair following balloon angioplasty, the Tack® implant is a first-of-its kind device for patients with peripheral arterial disease (PAD) and/or critical limb ischemia (CLI).

“The Tack System provides a much needed therapeutic option for treating dissections in the superficial femoral or popliteal arteries following balloon angioplasty,” said Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. “I am very pleased with my experience using the implant and I am excited to incorporate this technology into my above and below the knee treatment algorithms going forward.”

Patients treated with balloon angioplasty frequently suffer from dissections. Often overlooked, undiagnosed and untreated, dissections can lead to acute thrombosis and arterial occlusions, which lower long-term patency rates and require repeat procedures. Designed to resolve these dissections while leaving minimal metal behind, the Tack implant is uniquely designed to preserve vessel integrity, minimize vessel inflammation and enhance blood flow.

“With the Tack System, balloon angioplasty results are improved regardless if it is drug-eluting or not,” noted Dr. Michael K.W. Lichtenberg, Chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Germany. “Based on my initial experience, I am confident this new paradigm of focal dissection repair will become standard of care for patients undergoing PAD interventions.”

“Commercializing the Tack Endovascular System is a major achievement for our company and ultimately for patients undergoing balloon angioplasty,” stated Howard Rosen, Vice President of Marketing & Business Development at Intact Vascular. “We are excited to bring this impactful technology to market and look forward to expanding our commercial efforts in Europe.”

 

About Intact Vascular and the Tack Endovascular System

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. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) or four for below-the-knee (BTK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

 

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has completed enrollment. 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.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the 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

1Bosiers M, Scheinert D, Hendricks 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.

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.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.

Intact Vascular Announces Enrollment Completion of TOBA II BTK Clinical

By | 2018 Press Releases, Press Releases

First-of-its-kind study designed to demonstrate safety and efficacy of the Tack Endovascular System® in treating post-PTA dissections below the knee. January 2, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced its Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial successfully completed enrollment, ahead of schedule.

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