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

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.”

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Intact Vascular Announces Enrollment Completion of TOBA II BTK Clinical Trial

First-of-its-kind study designed to demonstrate safety and efficacy of the Tack Endovascular System® in treating post-PTA dissections below the knee

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. This study further augments Intact Vascular’s robust clinical program and is notably the first pivotal trial investigating a permanent vascular implant in arteries below the knee.

“Patients with critical limb ischemia (CLI) experience painful symptoms and are at increased risk of amputation. Unfortunately, therapeutic options are very limited, and no scaffolding solutions are currently FDA-approved for BTK interventions,” commented George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, Raleigh, North Carolina, Co-Principal Investigator for the TOBA II BTK study. “The potential to have a treatment option that maintains vessel integrity and improves blood flow will have a significant clinical impact for treating patients with below-the-knee disease.”

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Intact Vascular to Sponsor Post-Angioplasty Dissection Symposium and Present an Update on the TOBA II Pivotal Study Results at the 2018 VEITH Conference

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 during a lunch symposium co-sponsored with Philips at the 45th annual VEITH conference in New York City on Thursday, November 15th. Following the symposium, an update on the company’s TOBA II pivotal trial will be presented.

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Intact Vascular Announces Positive One-Year Data from the TOBA II Clinical Trial

First-of-its-kind study designed to demonstrate safety and efficacy of the Tack Endovascular System®in treating post-PTA dissections

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced at the 15th annual VIVA conference in Las Vegas that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial successfully achieved both primary and secondary endpoints. One year results from the TOBA II study were presented in the late-breaking scientific session by William Gray, M.D., System Chief, Division of Cardiovascular Disease at Main Line Health, President, Lankenau Heart Institute and Principal Investigator for the TOBA II trial.

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Intact Vascular Welcomes Publication of iDissection Classification Study Results in Journal of Invasive Cardiology

Dissections post-atherectomy are significantly underdiagnosed on angiogram and are detectable utilizing intravascular ultrasound (IVUS)

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.

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Intact Vascular Sponsors Symposium on Post-Angioplasty Dissections

Post-PTA dissection: clinical impact, identification and treatment

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.

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TOBA II BTK Trial Enrollment Ahead of Schedule for the Tack Endovascular System® in Below the Knee Disease

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial surpassed the 100 patient milestone, advancing enrollment well ahead of schedule.

The TOBA II BTK is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the mid/distal popliteal, tibial and peroneal arteries during the treatment of critical limb ischemia (CLI) patients. The Tack implant is a first-of-its kind device for precision dissection repair following balloon angioplasty. The system is designed to help maintain vessel integrity and improve blood flow to promote healing, improve outcomes and preserve limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options. 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. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

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Intact Vascular Press Release: FDA Approves 6-Month Primary Endpoint for the Tack Endovascular System® in Below the Knee Disease

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial from 12 months to 6 months.

The TOBA II BTK study enrolled its first patient in February, 2017 and is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). The Tack Endovascular System is a new technology designed to repair dissections (or tears) in the artery wall that frequently occur as a complication of balloon angioplasty. The system is intended to provide physicians with an alternative for repair of dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

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Intact Vascular Adds Howard Rosen to its Executive Management Team as VP Marketing and Business Development

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that Howard Rosen has joined its executive management team as Vice President of Marketing and Business Development. In this position, Mr. Rosen will lead the company’s efforts to prepare for commercialization of its Tack Endovascular System® for the repair of dissections following peripheral artery angioplasty.

“Howard brings deep experience in both upstream and downstream marketing, as well as first-hand knowledge of the peripheral vascular marketplace and our customers,” said Bruce J. Shook, Intact Vascular’s President and CEO. “Howard is a welcome addition to our team as we move through the Pre-Market Approval (PMA) application process and toward market introduction of our products,” Shook continued.

Prior to joining Intact Vascular, Mr. Rosen’s career included twenty-one years at Boston Scientific Corporation (NYSE: BSX), where he began his career as a sales representative and rose through the marketing ranks to hold positions of increasing responsibility in the peripheral vascular interventions and cardiovascular businesses. Mr. Rosen most recently served as Vice President of the Cell Processing Franchise at the Haemonetics Corporation (NYSE: HAE).

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Intact Vascular Announces Completion of Enrollment in the Tack Optimized Balloon Angioplasty II (TOBA II) Clinical Trial

The TOBA II clinical trial studies the combination of Intact Vascular’s Tack Endovascular System®with both standard and drug coated balloon angioplasty in the treatment of patients with peripheral artery disease (PAD)

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial has completed enrollment. A total of 210 patients have been enrolled in TOBA II at 33 sites in the U.S. and Europe.

The TOBA II trial is a prospective, multi-center, two-arm, non-randomized study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard or drug coated balloon (DCB) angioplasty in the arteries above the knee. Target vessels include the superficial femoral artery (SFA) and the proximal segment of the popliteal artery. The Tack Endovascular System is a new technology designed to repair dissections (or tears) in artery walls that frequently occur as a complication of standard or DCB angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

The design of TOBA II is unique in that it permits use of the Tack® system following either standard (uncoated) balloon angioplasty or drug coated balloon angioplasty using the BARD Lutonix® DCB. Patients are enrolled in either group based upon the treating physician’s clinical judgement. The primary effectiveness endpoint for TOBA II is Duplex derived patency at 12-months following treatment.

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