Category: News

Gembloux, Belgium, September 25, 2025 – Intressa Vascular SA, a clinical-stage MedTech company, today announces the first patient enrolment in the EXTENSO clinical study (NCT06675617) in Germany. This study evaluates the innovative multilayer Allay® Aortic Stent as distal extension to stent graft in patients with TBAD eligible for thoracic endovascular repair with stent grafts and their dissection extending to the celiac trunk or beyond.

Aortic dissection remains a severe cardiovascular emergency with high morbidity and mortality. Current therapies have important limitations, particularly when the dissection extends into segments of the aorta supplying vital organs and extremities. The impermeable design of standard stent grafts restricts their applicability, leaving portions of the diseased aorta untreated and patients at risk of subsequent surgical procedures. This clinical study aims to investigate whether the Allay® Aortic Stent, when used alongside a conventional stent graft, can provide a more extensive repair, limit aortic growth, and decreasing the long-term need for reintervention.

We are proud to announce that the first patient is now enrolled in EXTENSO in Germany and has been successfully treated with a combination of a thoracic stent graft and the Allay® Aortic Stent. The study is also enrolling in Uzbekistan and in Belgium, while more interested investigators/centers are expected to open in the coming weeks as regulatory approvals are obtained in other European countries.

“Each new patient in the EXTENSO study brings the concept of distal extension to a stent graft closer to reality. This trial will bring confirmatory data about the adjunctive use of the Allay® Aortic stent in these patients eligible to conventional stent graft with their aortic dissection extending into the abdominal aorta. I am delighted to see the study advancing with the first patient enrolled in a German center”, states Professor Christoph Nienaber, from Royal Brompton Hospital, NHS Trust, London, Chair of the Study Steering Committee.

“Being the first to enroll and treat a patient in Europe with the Allay® Aortic Stent as part of the EXTENSO study is both an honor and an exciting milestone. As physicians, we are driven by innovation that can truly change the standard of care of this life-threatening cardiovascular condition, and this study represents an important step in that direction”, indicates Professor Andrej Schmidt, MD, Senior Interventionalist at University of Leipzig Medical Center.

“With this first EXTENSO patient in Germany, we reaffirm our commitment to providing a better treatment option for physicians and patients with aortic dissection”, tells Pierre Douette, Intressa Vascular CEO. “We are excited to start the EXTENSO study in Europe and continue supporting the (future) investigators in evaluating the potential of the Allay® Aortic Stent in this underserved disease”, adds Eric Boulogne, VP Clinical Affairs at Intressa Vascular.

Gembloux, Belgium, June 2, 2025 – Intressa Vascular SA, a clinical-stage MedTech company, today announces the first patient enrolment in the EXTENSO clinical study (NCT06675617). This study will evaluate the Allay® Aortic Stent as distal extension to stent graft in patients with TBAD eligible for thoracic endovascular repair with stent grafts and their dissection extending to the celiac trunk or beyond.

Aortic dissection is a life-threatening cardiovascular condition with poor clinical outcome. Current treatment options are suboptimal, especially when the dissection extends to areas of the aorta where vessels feeding organs and limbs branch off from the aorta: as per the impermeable nature of stent grafts, their use is limited to a part of the aorta, leaving the rest untreated and the patient at risk of future reoperation. The goal of the study is to evaluate the use of the Allay® Aortic Stent in combination with such stent graft, to treat the aortic dissection extensively, reduce the growth of the aorta and therefore the need for late reoperation.

We are proud to announce that the first patient is now enrolled in EXTENSO and has been successfully treated with a combination of a thoracic stent graft and the Allay® Aortic Stent. The study is currently open for enrolment in Belgium, Germany and Uzbekistan, with additional regulatory submissions ongoing in a series of other European countries. As of today, 27 investigators/centers have confirmed their interest in participating in the study.

“The concept of distal extension to a stent graft to treat patients when their dissection extends far into the abdominal aorta is a valuable option; it’s now years we are searching for the appropriate device to provide better scaffolding of the distal dissected aorta, stabilizing the true lumen, hopefully better remodeling without any risk of side branch occlusion! I am thrilled to see this being evaluated in the EXTENSO study”, states Professor Christoph Nienaber, from Royal Brompton Hospital, NHS Trust, London, Chair of the Study Steering Committee.

“It is exciting to see the first patient enrolled in the EXTENSO study. We need new options to provide our patients with aortic dissection with extensive treatment and reduce the risk of reinterventions. The Allay® Aortic Stent bears the potential to be such a solution” shares Associate Professor Wolf-Hans Eilenberg MD, PhD, FEBVS from Medical University of Vienna, Coordinating Investigator of the EXTENSO study.

“This first patient enrolled in the EXTENSO clinical study is a major milestone in the company’s clinical development and product registration activities which are supported by our investors” tells Pierre Douette, Intressa Vascular’s CEO. “Patients with aortic dissection deserve better treatment options than what they are proposed today, so they no longer have to fear future reinterventions. We are thrilled by the start of the EXTENSO study, which evaluates the potential of the Allay® Aortic Stent to be such an option for patients and physicians”, adds Eric Boulogne, VP Clinical Affairs at Intressa Vascular.

Originally awarded in France, this prestigious award has expanded to 15 different countries, reflecting the growing involvement of companies in biomedical research and development. Since 2023, The award has been divided into two events: The Prix Galien Medical Devices and The Prix Galien pharmaceuticals.

This year, The Galien Ceremony for Medical Devices took place in Brussels, coinciding with the MedTech Meetup where Diane, Chief Strategy Officer of Intressa Vascular, pitched our project.

For Intressa Vascular, this recognition as medical device with the most promising design from the Galien Foundation acknowledges the innovative characteristics of the stent, which relays on its mechanical properties and 3D-porosity to provide extensive coverage of the dissected aorta, aiming at reducing the need for reintervention and the frequency of side effects.

The satisfaction is even greater as this award comes from experts in medical and academic fields, underscoring our ability to meet the critical needs of the medical community.

This victory strengthens our determination to continue our mission of innovation and supports our efforts in bringing a better treatment option for aortic dissection.

Former medical device top executive, Denis Gestin, brings more than thirty years of experience in the management and commercial development of medical technologies companies, having held positions as SVP for Abbott and President of the International Division (OUS) at St. Jude Medical. Today active in the Board of Directors of several start-ups, Denis shares Intressa Vascular’s value and dedication to bringing new options to patients with aortic dissection, a life-threatening cardiovascular condition with poor outcome and suboptimal treatment options on an addressable market of more than EUR 2 billion.

“Denis Gestin will be a critical member of the Board of Director at Intressa Vascular, to advance the company’s product development, including clinical studies and regulatory pathways, and prepare market adoption of the multilayer stent in aortic dissection”, says Philippe Felten, Chairman of the Board.

“I believe that Intressa Vascular is well positioned to make a great impact on the treatment of aortic dissection through their unique multilayer stent braiding technology, said Denis Gestin. I am excited to join Intressa Vascular and work with the distinguished and accomplished team of employees, directors and scientific advisors to better support patients facing such life-threatening disease as aortic dissection”, says Denis Gestin, Director of the Board.

“We are very excited to welcome Denis as an independent board member. As we are progressing closer to the market, his expertise and international exposure both as MedTech executive and Director will be highly valuable and will complement our team with high impact”, says Pierre Douette, CEO.