Tag: CABG

Vascudyne presents at EACTS 2026 in Barcelona. Abby Krouse describes research to attendee.

Vascudyne’s Lab-Grown Vessel Passes the Two-Year Mark Supplying Blood to a Patient’s Heart as a Coronary Bypass

Two-year clinical follow-up presented at EACTS 2026, highlighting the potential of Vascudyne’s bioengineered platform technology
EACTS Vascudyne Photos

Vascudyne presents at EACTS 2026 in Barcelona. Abby Krouse describes research to attendee.

BARCELONA, Spain and ST. PAUL, Minn., Oct. 08, 2026 (GLOBE NEWSWIRE) — Vascudyne, Inc., a clinical-stage medical device company developing off-the-shelf bioengineered implants designed to regenerate into the patient’s own living tissue, today announced the presentation of two-year clinical data for its acellular tissue-engineered vessel used as a coronary artery bypass graft. Together with recently published preclinical findings, the data further support the potential of Vascudyne’s bioengineered tissue platform to provide living graft replacements without the need for tissue harvest from the patient. The results are being presented at the 40th EACTS Annual Meeting in Barcelona, Spain. The problem: today’s bypass surgery depends on borrowing a vessel from the patient In coronary artery bypass surgery, a surgeon creates a new route for blood to flow around a blocked artery in the heart. To do that, they need a replacement blood vessel, and today the only option is to borrow one from the patient. That means a second incision, often in the leg, along with extra pain, scarring and recovery time. Even then, the borrowed vein is not always healthy enough to use. Many leg veins used in bypass surgery narrow or close within the first year, and about one in five patients have no suitable vein to use at all. There is currently no approved, ready-to-use small blood vessel that surgeons can simply take off the shelf. A different approach: a vessel grown in the laboratory Vascudyne grows human tissue blood vessels in a bioreactor and then removes all the living cells, leaving behind the natural collagen based structure. Because no cells remain, the body does not reject it, and the vessel can be stored on a hospital shelf until a surgeon needs it. After implantation, the patient’s own cells move in and gradually turn it into living tissue. The goal is a graft that becomes part of the patient. The patient results: two years and sustained blood flow The case presented at EACTS describes a patient who received the lab-grown vessel during coronary artery bypass surgery. Imaging performed repeatedly over two years showed that the bioengineered vessel remained open, with blood flowing normally. Throughout follow-up there was no clotting, abnormal swelling of the vessel, bleeding, major heart event or problem related to the device. This is the longest documented clinical patency, or continuous blood flow, reported to date for a Vascudyne tissue-engineered vessel. Further, Vascudyne has recently completed enrollment in its European CABG feasibility clinical study. What animal studies show: blood flow maintained after blood thinners were stopped Separately from the patient case above, Vascudyne recently published an 18-month study in sheep in the journal Nature Communications. The bioengineered vessels, used as coronary bypass grafts maintained function. Blood thinners (anticoagulation) were then stopped, and the lab-grown vessels remained patent and functional for the rest of the 18-month study. Explant analysis demonstrated living blood vessels. The detail that matters most was inside the vessel. Healthy blood vessels are lined with a thin layer of cells called the endothelium, that keeps blood flowing without clotting. A manufactured graft starts out without this lining. These vessels grew that lining, which is why they could stay open after the blood thinners were stopped. When examined at the end of the study, they had become living blood vessels. To the company’s knowledge, this is the first published evidence of lab-grown vessels in the heart that developed a working inner lining and stayed open for a full year after blood thinners were stopped. How we envision improvement in coronary disease patient care in coming years “For sixty years, bypass surgery has relied on a vessel taken from the patient’s own body, and often what is borrowed is not ideal,” said Zeeshan Syedain, PhD, Chief Executive Officer of Vascudyne. “In fact, we have heard from many patients about the pain of that second wound in their leg. We want to give surgeons a better option and spare patients the second incision. What we see at two years in the clinic, and at eighteen months in animals without anticoagulation, is very promising for Vascudyne’s tissue-engineered vessel. We believe our bioengineered blood vessels have the potential to transform not only coronary bypass surgery, but many cardiovascular diseases.” “Finishing enrollment in our European clinical trial and now reporting two-year results is a major milestone for our bypass program,” said Abrielle Krouse, Director of Clinical Affairs at Vascudyne. “The clinical need is significant. More than 400,000 bypass surgeries are performed each year in the United States and Europe, yet many vein grafts fail within the first year, and roughly one in five patients has no good vein to use. A ready-to-use vessel that can regenerate into the patient’s own tissue could help to close that gap. Coronary bypass surgery is our first step. We are developing the same technology for other heart and blood vessel conditions where surgeons need implants that can become living, integrated tissue.” About Vascudyne Vascudyne, Inc. is a clinical-stage medical device company based in St. Paul, Minnesota. Its technology, developed at the University of Minnesota, grows human tissue in bioreactors and then removes the cells, creating ready-to-use implants that do not require anti-rejection drugs and that the patient’s own cells turn into living tissue after implantation. The company is developing implants for heart bypass surgery, repair of heart defects in children, and heart valve replacement. Vascudyne manufactures its products in-house under GMP in dual ISO 7 clean rooms. Vascudyne’s devices are investigational and are not approved for commercial use. Media and investor contact Katherine Lindsaycontact@vascudyne.com · vascudyne.com Forward-looking statements: This release contains forward-looking statements regarding clinical development plans, regulatory progress and commercial potential. Clinical results from individual cases and preclinical models may not predict outcomes in larger trials. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/993bc055-9d8e-4de1-bec8-c8c6b0888160

A breakthrough in coronary bypass surgery: AMT Medical’s SAFE-CAB results published in The Journal of Thoracic and Cardiovascular Surgery

Video: How does AMT’S ELANA® system work?   The first suture-less, beating-heart bypass connection, shown to be safe with promising early effectiveness in a peer-reviewed clinical trial. AMT Medical reports one-year results from the SAFE-CAB II prospective clinical trial in The Journal of Thoracic and Cardiovascular Surgery1 (link). Its results provide important first-in-human clinical experience with a technology designed to support a new generation of bypass surgery that could enable more standardized procedures and broader adoption of minimally invasive and robotic approaches. At a glance A first-of-its-kind clinical trial: the ELANA® system replaces hand-sewing of the bypass connection with a sutureless, laser-assisted technique that keeps the coronary artery open throughout surgery.Strong safety profile: Only 2.9% of patients experienced a device-related major adverse cardiac event (MACE) within one year, meeting the pre-specified non-inferiority threshold (p = 0.0033).Strong effectiveness: 92.5% of bypass connections remained fully open at six months across the full study, rising to 97.5% with the latest-generation laser catheter, in line with the performance gains anticipated from this device iteration.Reproducible by design: a defined six-step procedure, described in detail in a companion technical publication in the Journal of Visualized Surgery (JOVS, 2026). Published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS), the flagship journal of the American Association for Thoracic Surgery. EDE / UTRECHT, The Netherlands, 16 July 2026 — AMT Medical B.V., a clinical-stage Dutch medical technology company, today announced that the one-year results of the SAFE-CAB II clinical trial have been published in The Journal of Thoracic and Cardiovascular Surgery. The study is the first prospective clinical evaluation of the ELANA® Anastomotic System, a new technology designed to make coronary artery bypass grafting (CABG) more reproducible and accessible to a far broader group of patients. Why this matters, for patients and for healthcare systems Coronary artery bypass grafting is the most durable treatment for advanced coronary artery disease, with around one million procedures performed worldwide every year. Despite decades of innovation, the most critical step of the operation, sewing the bypass graft onto the diseased coronary artery by hand, has remained essentially unchanged since the 1960s. It is delicate, time-consuming, and the single technical step most often cited by surgeons as the obstacle to wider use of minimally invasive and robotic bypass techniques. The ELANA® Anastomotic System replaces that hand-sewn connection with a small titanium clip and a precisely controlled laser pulse. The connection is made before the artery is opened, so the coronary artery never has to be clamped or temporarily blocked, blood keeps flowing throughout the procedure. For patients.  A sutureless, flow-preserving connection is a foundational enabler of minimally invasive and robotic CABG, approaches associated in the published literature with smaller incisions, less surgical trauma, shorter hospital stays, faster return to daily life and a reduced risk of complications compared with traditional open-chest surgery. SAFE-CAB II now provides the first prospective clinical evidence that this enabling technology is safe and effective in human use. For surgeons and hospitals.  A defined, six-step mechanical procedure replaces a hand-sewn step requiring 8–12 hand-sewn stitches per anastomosis, that today is highly skill-dependent. By removing the human-factor variability inherent to hand-sewing, the procedure is designed to reduce variation regardless of which surgeon performs it. For healthcare systems.  The shorter recovery, fewer complications and shorter ICU and hospital stays associated with minimally invasive bypass approaches create the potential for meaningful improvements in capacity utilization and cost efficiency, where freed-up capacity can be put to use. An internal health-economic assessment, based on benchmark data from major CABG literature, estimates that, at scale, direct CABG-related hospital costs could be reduced by 35-50% relative to conventional open-chest CABG, with additional productivity gains for working-age patients through faster return to work. “For the first time, a rigorous prospective trial shows that the most challenging step of a bypass operation can be performed without sutures on a beating heart, and without ever interrupting blood flow to the patient’s coronary artery. That is genuinely new. It is the technical breakthrough the field has been waiting for to make modern, less invasive bypass surgery available to many more patients than today.” — Bart P. van Putte, MD PhD, Principal Investigator; Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, and Amsterdam UMC The SAFE-CAB II trial in brief SAFE-CAB II (registered as DRKS00020545 and NCT07005843) is a prospective, single-arm clinical trial conducted at St Antonius Hospital in Nieuwegein, The Netherlands, in close collaboration with Deutsches Herzzentrum der Charité in Berlin, Germany. Between June 2023 and September 2024, 71 patients undergoing elective CABG received the bypass connection between the left internal thoracic artery and the left anterior descending coronary artery, the most clinically important bypass in the operation, using the ELANA® system. Patients had an average age of 71 years; the average number of bypass connections per patient was 3.5. All angiographic data were independently reviewed by Cardialysis (Rotterdam, The Netherlands), one of the leading academic core laboratories in cardiovascular research. The trial was monitored end-to-end by an independent contract research organization (HEMEX AG) under the continuous oversight of an independent Data Safety Monitoring Board, and conducted in compliance with the Declaration of Helsinki, the EU Medical Devices Regulation, and ISO 14155 and 14971 standards. What the data show Primary endpoint met: device-related serious cardiac events at one year occurred in 2.9% of patients, statistically non-inferior to the historical surgical benchmark (p = 0.0033).Six-month patency: 92.5% across the full trial, and 97.5% in the subgroup treated with the latest-generation laser catheter. These rates match the upper range of what is reported for the best hand-sewn bypasses.In a subset of patients with an angiographically uncertain result, intravascular ultrasound confirmed the bypass connection was fully open and unobstructed.Total one-year serious cardiac events was 8.7%, as expected.No safety concerns related to the device were identified by the independent Data Safety Monitoring Board. How the ELANA® Anastomotic System works The ELANA® technology was originally developed at UMC Utrecht in the Netherlands for bypass surgery in the brain, received CE marking in 2008 and FDA clearance in 2012 for that indication, and has since been used in more than 1,000 patients worldwide. Over the past decade, AMT Medical’s team has re-engineered the platform specifically for the coronary anatomy, with extensive preclinical validation including ex-vivo human hearts and large-animal studies. In the operating room, the surgeon uses the ELANA® system to attach a small titanium clip to the coronary artery and then fires a controlled laser pulse that creates a clean opening within the clip. The connection is made in a fully defined six-step sequence rather than relying on hand-sewn stitches one at a time. Because the connection is made before the artery is opened, blood continues to flow to the heart muscle throughout the procedure. The six-step procedure is described in detail in a separate peer-reviewed technical publication in the Journal of Visualized Surgery (JOVS, 2026)2. Market opportunity and next steps Coronary artery disease is the leading cause of death globally, and CABG remains the most durable treatment for its most advanced forms. The global CABG device market represents a substantial and recurring annual opportunity, and is expected to expand further as the percentage of procedures performed using minimally invasive and robotic approaches grows. Today, the lack of a reliable sutureless connection technology is widely viewed as the single most important barrier holding that transition back. With SAFE-CAB II peer-reviewed and published, AMT Medical now has the clinical foundation to move into the next phase of its commercial and regulatory pathway: Preparing CE marking for open and MIDCAB (minimally invasive direct coronary artery bypass) indications under the EU Medical Devices Regulation.Preparing an Investigational Device Exemption submission with the U.S. Food and Drug Administration for an Early Feasibility Study, in collaboration with leading U.S. cardiac surgery centers with discussions currently underway with several leading academic centers.Initiating the next generation of clinical trials in minimally invasive and robotic settings, including a planned multivessel investigation.Continuing the two-year follow-up of the SAFE-CAB II cohort. Earlier this year, AMT Medical appointed Geert van Gansewinkel as Chief Executive Officer to lead the company through this next growth phase. Mr. van Gansewinkel joined AMT Medical from GATT Technologies, where as CEO he led the company through CE marking in 2023, FDA PMA approval in 2025, and a successful acquisition by Johnson & Johnson in 2025. Founder Rutger Tulleken transitioned to the role of Founder and Strategic Advisor, where he continues to support platform innovation, intellectual property development, grant funding and collaboration with surgeons and research institutions. AMT Medical has raised over EUR 40 million to date, including a USD 25 million Series B in 2025 led by Bender Analytical Holding B.V., with participation from Invest-NL, the European Innovation Council Fund and Oost NL. “Peer-reviewed publication in JTCVS is a defining milestone for AMT Medical. It places the ELANA platform on a solid clinical foundation, independently adjudicated and reviewed by the international cardiothoracic surgery community. We now have everything we need to take the next steps: CE marking for open and MIDCAB indications, an IDE submission with the FDA in collaboration with leading U.S. centers, and the next generation of trials in minimally invasive and robotic surgery. Our goal is simple, to make high-quality bypass surgery, with faster recovery and fewer complications, available to far more patients than today.” — Geert van Gansewinkel, Chief Executive Officer, AMT Medical B.V. About AMT Medical B.V. AMT Medical B.V. is a Dutch medical technology company developing the ELANA® Anastomotic System for coronary artery bypass surgery. Founded on technology pioneered at UMC Utrecht for neurovascular bypass surgery and brought to market under CE and FDA approvals by the original ELANA team, AMT Medical is headquartered in Ede with laboratory facilities in Utrecht, The Netherlands. The company is ISO 13485-certified and holds more than 40 patents. AMT Medical collaborates with leading cardiac surgery centers in The Netherlands, with Charité – Universitätsmedizin Berlin in Germany and is building relationships with leading academic centers in the United States, supported by an international network of cardiothoracic surgery and cardiology key opinion leaders. DISCLAIMERThe ELANA® Anastomotic System for coronary artery bypass is an investigational device. It has not yet received CE marking and is not cleared or approved by the U.S. FDA for commercial sale. For more information, visit www.amt-medical.nl or find us on LinkedIn. REFERENCES 1. Beukers SHQ, Jacobs S, Klein P, Bronkers G, Moormans LR, Ten Berg J, Falk V, van Putte BP. The first prospective Safety And eFfectiveness trial of the ELANA heart bypass system in Coronary Artery Bypass grafting (SAFE-CAB II trial). The Journal of Thoracic and Cardiovascular Surgery. 2026.  LINK 2. Beukers SHQ, et al. The ELANA Heart Bypass System: a sutureless, laser-assisted technique for coronary artery bypass anastomosis. Journal of Visualized Surgery (JOVS). 2026, LINK MEDIA AND INVESTOR CONTACTS AMT Medical B.V.   —   Ede / Utrecht, The NetherlandsGeert van Gansewinkel, Chief Executive Officerinfo@amt-medical.nl   •   +31 85 105 7070 LifeSpring Life Sciences Communication   —   AmsterdamLeon Melenslmelens@lifespring.bio   •   +31 6 538 16 427 ELANA® is a registered trademark of AMT Medical B.V. —  END —
Attachments

The Journal of Thoracic and Cardiovascular Surgery – ELANA anastomotic system

AMT_Medical_SAFE-CAB_JTCVS_Press_Release

Humacyte Presents Six-Month Human Acellular Vessel™ (HAV™) Coronary Artery Bypass Graft (CABG) Data at the American Heart Association Scientific Sessions 2022 Meeting

Six-month primate HAV CABG model demonstrates patency, recellularization and remodeling resembling native blood vessels HAV may address many limitations of current standard of care grafts used in CABG procedure DURHAM, N.C., Nov. 07, 2022 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered […]

Humacyte Preclinical Data on Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting (CABG) Presented at American Heart Association Meeting

— Preclinical model data expected to support development of small diameter HAV to treat patients with coronary artery disease– — Small-diameter HAV observed to maintain patency and exhibit host-cell remodeling at six months post-implantation in a non-human primate model– –Results presented at American Heart Association Basic Cardiovascular Sciences Scientific Sessions 2022 […]

Humacyte Presents Preclinical Results of Small-Diameter HAV™ for Use as a BTT Shunt in Pediatric Heart Disease at American Heart Association’s Scientific Sessions 2021

— Patency and host cell remodeling of the HAV were observed in all study implants – — Preclinical study is one component of Humacyte’s expansion of the testing of the HAV in a broader cardiac bypass surgery application – DURHAM, N.C., Nov. 16, 2021 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a […]

Getinge Opens New Acute Care Section in the Experience Center in Germany

GETINGE, Sweden, June 5, 2019 /PRNewswire/ — Getinge has opened up a brand new acute care section focused on Cardiovascular Procedures in one of its Experience Centers located in Rastatt, Germany. Here, customers have the possibility to learn more about the solutions that Getinge provides to not only aid in the Coronary Artery Bypass Surgery […]

Somahlution Announces Patient Enrollment In Duragraft CABG European Registry

JUPITER, Fla., Jan. 4, 2017 /PRNewswire/ — Somahlution, a global biotechnology company developing products to reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications, today announced enrollment of the first subject in their DuraGraft CABG European Registry. The registry will evaluate the company’s flagship […]