Vivasure Medical

Vivasure Medical Announces Launch of the PerQseal® Large-Bore Closure Device

The world’s first fully absorbable, patch-based large-bore percutaneous closure device is now available to European physicians and patients

GALWAY, Ireland - Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the European launch of the PerQseal® closure device for large-bore transcatheter procedures.

Novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), require large-bore femoral artery access. Closure of these large-bore access sites is challenging and has been associated with significant vascular and bleeding complications.

PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore arterial punctures. The PerQseal technology consists of an intravascular patch that seals the vessel from the inside, returning the artery to its natural state.

“Closing the artery has been a concern since we started using transcatheter techniques for valve implantation,” says Prof. Horst Sievert, of the CardioVascular Center in Frankfurt, Germany. “The PerQseal device is a very innovative solution for closing large holes, and we are enthusiastic to make it part of our armamentarium.”

“We’re excited that the PerQseal device is now widely available to European physicians, providing a safe and simple option for the closure of large puncture holes that leaves behind no sutures, metal implants, or collagen,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “This commercial launch is a key milestone for Vivasure as we journey to enable better patient outcomes in fully percutaneous large-bore endovascular procedures.”

“In my first clinical experience with PerQseal, I found the device intuitive and well controlled, which helped me quickly learn how to use the technology safely and successfully,” said Dr. Saib Khogali, Heart & Lung Centre, New Cross Hospital Wolverhampton, United Kingdom. “I believe the PerQseal has the potential to be an important large-hole closure device in many TAVR and EVAR patients.”

About Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

The PerQseal® is not available for sale in the United States.

Contacts

Vivasure Medical

Sierra Smith, 408-540-4296

sierra@healthandcommerce.com

Vivasure Enrolls First Patient in Frontier IV Clinical Trial

International Trial Designed to Expand Indications for PerQseal Closure Technology
 

GALWAY, Ireland -Vivasure Medical® (“Vivasure”) is pleased to announce the successful enrollment of the first patient in the Frontier IV clinical study, a non-randomized multicenter international trial, designed to expand the indications of its proprietary PerQseal® large arteriotomy closure technology. The patient was enrolled by Dr. Peter Crean at the Blackrock Clinic, Dublin, Ireland.

Large arteriotomies (12F+) are vessel punctures created to facilitate endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), balloon valvuloplasty (BAV) and ventricular assist devices (VAD). PerQseal is the world’s first fully absorbable, patch-based large-bore percutaneous closure technology.

“Driven by clinical and economic outcomes data, percutaneous access-site management has become an increasingly important aspect of TAVR procedures,” said Dr. Christoph Naber of the department of cardiology and angiology, Contilia Heart and Vascular Centre, Essen, Germany, and TAVR principal investigator of Frontier IV. “I strongly believe PerQseal, which is designed specifically to address large arteriotomies, will help improve outcomes for these patients.”

“We are very excited to begin the Frontier IV trial as the next phase in our commitment to build the clinical experience with PerQseal,” said Gerard Brett, co-founder and CEO of Vivasure. “A percutaneous approach has now become the gold standard for procedures such as TAVR and EVAR, driven by clinical outcomes data. As patient volumes increase, access site management and closure has become an increasingly important aspect of complication and cost reduction. The data from this trial will be used to support our goal of expanding the indication range of the PerQseal technology.”

 

About PerQseal®

PerQseal® utilises a fully absorbable, intravascular patch, which seals large arteriotomies from the inside. It is comprised of a synthetic polymer implant, and an easy-to-use, ergonomically designed delivery system. The implant has a flexible, low-profile intravascular patch and a supporting scaffold. A portion of the scaffold extends through the arteriotomy, and includes a locator which helps maintain the implant in position. After deployment, the implant is rapidly endothelialised and fully absorbed.

 

About Vivasure

Based in Galway, Ireland, one of Europe’s largest medtech hubs, Vivasure is focused on the development of bioabsorbable implant technologies with vascular applications. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors.

 

Contacts
for Vivasure Medical
United States:
Jessica Volchok, +1 310-849-7985
jessica@healthandcommerce.com
or
Europe:
Jonathan Neilan, +353 (0)86 231 4135
jonathan.neilan@fticonsulting.com

 

 

 

 

Vivasure Medical Appoints Robert (Chip) Hance to Company’s Board of Directors

25-Year Medical Device Veteran Brings Deep Industry, Commercialization Experience

Galway, Ireland — Vivasure Medical™, a company developing a novel bioabsorbable technology for percutaneous vessel closure, today announced the appointment of Robert (Chip) Hance to the company’s board of directors. 

Hance is a 25-year veteran of the medical device industry. He is the former CEO of Creganna Medical, a private equity-backed Ireland-based supplier to the minimally invasive medical device industry, which was recently acquired by TE Connectivity. Previously, he served as an Entrepreneur in Residence at the U.S. Food and Drug Administration (FDA) and in multiple executive roles at Abbott including president of Abbott Vascular, president of Abbott Diabetes Care, president of Vascular Devices and divisional vice president of Abbott Diagnostics in Europe.

“I can think of no one better suited than Chip to help lead Vivasure to the next stage in its evolution,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “Chip is a highly respected leader who has done much to advance innovation in our industry and to improve healthcare outcomes for patients around the world. We look forward to working closely with him as we further our mission of developing novel bioabsorbable technologies for percutaneous vessel closure.”

Hance’s appointment follows the recent completion of Vivasure’s Series C financing of €16.2M ($18.3M) to support European commercialization of the company’s PerQseal™ technology and to advance execution of a FDA regulatory study.

“I look forward to joining the Board as Vivasure advances its progress toward European market expansion and securing U.S. approval and commercialization of the company’s first product,” said Hance. “Vivasure’s closure device meets an important and growing clinical need and I am excited about the potential of this innovative technology to improve arteriotomy closure outcomes for patients.”

“On behalf of the entire Board and Vivasure’s investors, we are pleased to welcome Chip to the company’s Board of Directors,” said Bernard Collins, chairman of Vivasure’s Board of Directors. “His guidance will be invaluable as Vivasure moves toward this next stage of accelerated growth and opportunity.”

The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR). The device has been successfully evaluated in clinical studies, with patients treated in four European countries, achieving 97 percent device technical success with no major device-related complications. Long-term follow-up data has been collected to 12 months post-procedure, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021.

Hance holds a bachelor’s degree in chemical engineering from Massachusetts Institute of Technology and an MBA from Harvard Business School.

 

About Vivasure Medical    

Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com

 

Vivasure Medical Announces €16.2M ($18.3M) in Financing to Advance Commercialization of Closure Device in European Union and United States

Galway, Ireland —08 September, 2016 — Vivasure Medical™, a company developing a novel bioabsorbable technology for percutaneous vessel closure, today announced that the company has completed a Series C financing of €16.2M ($18.3M). The round was led by LSP (Life Sciences Partners) of The Netherlands, investing from its LSP Health Economics Fund, and co-led by Evonik Venture Capital (Germany), alongside Panakes Partners (Italy) with returning Series A and B investors led by Fountain Healthcare Partners, Ireland. 

The funding will support European commercialization of the company’s PerQseal™ technology to meet the growing demand for absorbable, percutaneous vessel closure products, as well as execution of a U.S. Food and Drug Administration (FDA) regulatory study.
 
The Vivasure Closure Device is the first product from the company’s PerQseal™ technology platform, and is the only approved fully bioabsorbable, sutureless and entirely synthetic option to close large-bore arteriotomies that result from percutaneous transcatheter procedures, including transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR). The device has been successfully evaluated in clinical studies, with patients treated in four European countries, achieving 97 percent device technical success with no major device related complications. Long-term follow-up data has been collected to 12 months post-procedure, and CE Mark was received in January 2016. The global market for large arteriotomy closure devices is growing rapidly and is expected to be more than $500 million by 2021. 

“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive percutaneous procedures,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “The Vivasure closure device is designed to be easy to use, allowing the surgeon and interventional physician to provide a complete repair at the access site, without leaving metal implants, sutures, or exogenous tissue behind. Our goal is to facilitate improved therapeutic results for patients over the open-surgery alternative, faster recovery times, and cost savings for the healthcare system.”

“We are excited to support this innovative company and its vision of improving outcomes for patients as it moves into commercialization in the European Union and enters the United States,” said Anne Portwich, partner, LSP. “We look forward to working closely with Vivasure as the company continues to work toward gathering more data through clinical studies that will facilitate expansion of adoption in European markets and drive U.S. approval and commercialization of its first product.”

An arteriotomy is a puncture hole in a vessel in the groin that provides access to arteries for catheter-based procedures. The proprietary Vivasure closure device offers physicians an easy-to-use and fully percutaneous (through the skin) alternative to surgical cut-down and sutured repair via a 3- to 5- centimeter incision for large-bore arteriotomies.  

About Vivasure Medical
Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com.

About LSP
LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, LSP’s management has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €1 billion of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is one of Europe’s leading life sciences investors. The LSP Health Economics Fund invests in innovative products that can increase the quality of health care, while reducing the cost of care. For more information, please visit: www.lspvc.com.

About Evonik VC
Evonik in the context of its venture capital activities wants to invest in total €100 million in promising start-ups with innovative technologies and in leading, specialized venture capital funds. Regional focuses on Europe, the United States and Asia. Currently, Evonik holds stakes in nine start-ups and four funds. More information is available at http://venturing.evonik.com/.

About Panakes Partners
Panakès Partners is a Venture Capital investor that finances medical companies, early stage startup and SMEs, with extremely promising products and great ambition, in Europe and Israel, improving both patient outcomes and healthcare economics. Investments focus on the medical device, diagnostics and healthcare IT fields. Panakès Partners is headquartered in Milan, Italy. www.panakes.it. 

About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. www.fh-partners.com.


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Media contacts:

United States:
Jessica Volchok, +1 (310) 849-7985
jessica@nicoleosmer.com

Europe:
Jonathan Neilan, +353 (0)86 231 4135
jonathan.neilan@fticonsulting.com

Vivasure Medical receives CE Mark for First and Only Fully Bioabsorbable Percutaneous Closure Device for Large-Bore Transcatheter Procedures

Sutureless Technology Designed to Facilitate Less-Invasive, Shorter Procedures

GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical today announced Conformité Européenne (CE) Mark approval of the world’s first fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. The Vivasure closure device is the first product from the company’s patented PerQseal™ technology platform, and is the only approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.

An arteriotomy is a puncture hole in a vessel in the groin that provides access to arteries for catheter-based procedures. Large-bore arteriotomies, such as those made to facilitate transcatheter aortic valve replacement (TAVR) and endovascular abdominal aortic aneurysm repair (EVAR), have traditionally required a surgical cut-down and sutured repair via a 3- to 5- centimeter incision. The proprietary Vivasure closure device offers physicians an easy-to-use and fully percutaneous (through the skin) alternative to sutured repair.

“Percutaneous transfemoral access is a key enabler for TAVR procedures, which are rapidly becoming standard of care for patients with aortic valve disease,” said Michael Laule, M.D., cardiologist at Charité University Hospital, Berlin. “The Vivasure closure device is an easy-to-use option that promises to significantly improve the patient experience and shorten overall procedure times by allowing physicians to utilize a fully percutaneous procedure to repair the access site.”

“The bioabsorbable nature of the Vivasure closure device allows the surgeon to provide a complete repair at the surgery site, which helps avoid stenosis and maintains the integrity of the vessel,” said Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic, director of the Scripps Prebys Cardiovascular Institute for Scripps Health, and chief medical officer of Vivasure Medical. “The demand for bioabsorbable solutions is growing as the transient nature of these products continues to demonstrate as good or better therapeutic results for patients.”

“Patients with aortic valve stenosis, abdominal aortic aneurysms and other serious conditions are increasingly treated with minimally invasive procedures that offer improved clinical outcomes and faster recovery times over the open surgery alternative. The Vivasure closure device is intended to further facilitate the less invasive nature of these treatments,” said Gerard Brett, co-founder and CEO of Vivasure Medical. “CE Mark is an important milestone for Vivasure as we continue development of our technology, which we plan to launch in Europe in the coming months.”

The Vivasure closure device includes a delivery system and single-use patch-like device. The system has been evaluated in clinical studies, with patients treated in four EU countries, achieving 97 percent device technical success with no major device related complications. Long-term follow-up data has been collected to 12 months post-procedure.

To view an animation of the Vivasure closure device, please visit www.vivasuremedical.com.

The Vivasure closure device is not currently approved in the U.S.

About Vivasure Medical
Based in Galway, Ireland, Vivasure Medical has developed a patented bioabsorbable implant platform technology for applications in vessel closure. Its first product from this PerQseal™ platform features a bioabsorbable implant and percutaneous delivery system, designed to close large arteriotomies. For more information visit www.vivasuremedical.com.

Contacts
for Vivasure Medical
Jessica Volchok
424-271-6471 (O)
310-849-7985 (C)
jessica@nicoleosmer.com