AMT Medical's Laser Tech Aims to Revolutionize Coronary Bypass Surgery

EDE, The Netherlands – July 16, 2026 – For more than half a century, the most critical step in coronary artery bypass surgery has remained a delicate, time-consuming art form, relying on a surgeon's steady hand to meticulously sew a new vessel onto a beating heart. Now, a Dutch medical technology company is poised to transform that art into a science, armed with a titanium clip, a laser, and compelling new clinical data.

AMT Medical today announced the publication of one-year results from its pivotal SAFE-CAB II clinical trial in The Journal of Thoracic and Cardiovascular Surgery, the flagship journal for the field. The study validates the safety and effectiveness of its ELANA® Anastomotic System, a first-of-its-kind device designed to create a sutureless bypass connection without ever stopping blood flow to the heart. This breakthrough is being hailed as a foundational enabler for a new generation of minimally invasive and robotic heart surgery, promising to make the life-saving procedure more standardized, accessible, and less traumatic for patients worldwide.

A Breakthrough in the Operating Room

At the heart of the innovation is a move away from the variability of the human hand. Traditional bypass surgery requires a surgeon to place 8 to 12 individual stitches to connect a new blood vessel to a diseased coronary artery—a step widely cited as the primary obstacle to adopting less invasive robotic techniques. The ELANA® system replaces this with a defined, six-step mechanical procedure. A surgeon uses the device to attach a small titanium clip to the target artery and then fires a precisely controlled laser pulse, which creates a clean, perfect opening. Crucially, this all happens before the artery is opened, meaning the coronary artery is never clamped or blocked.

The results from the 71-patient SAFE-CAB II trial, conducted at leading heart centers in The Netherlands and Germany, provide the first robust clinical evidence for this approach. The system demonstrated a strong safety profile, with only 2.9% of patients experiencing a device-related major adverse cardiac event (MACE) within one year, comfortably meeting its safety endpoint.

Effectiveness was equally impressive. At six months, 92.5% of the bypass connections remained fully open, a figure that rose to an exceptional 97.5% in the group treated with the latest-generation laser catheter. These patency rates, independently verified by the academic core lab Cardialysis, are on par with the best results seen from expert-performed hand-sewn bypasses.

“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,” said Dr. Bart P. van Putte, the trial's Principal Investigator. “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.”

The Patient Impact: Safer, Faster Recovery

While the technical achievement is significant, the most profound impact may be on the patient experience. By simplifying the most difficult part of the procedure, the ELANA® system is designed to unlock the full potential of minimally invasive direct coronary artery bypass (MIDCAB) and robotic-assisted surgery. These approaches avoid the need for a full sternotomy—the cracking of the breastbone—and are associated with smaller incisions, less surgical trauma, and dramatically reduced recovery times.

For patients, this translates into shorter hospital stays, a lower risk of complications like infection, and a much faster return to daily life. The prospect of avoiding the long, painful recovery of traditional open-heart surgery is a powerful motivator for the approximately one million people who undergo bypass surgery globally each year.

"The patient demand for less invasive options is immense," commented one senior cardiac surgeon not involved with the study. "For decades, the hand-sewn connection has been the biggest hurdle to making robotic bypass a mainstream reality. A standardized, reliable automated connector could be a complete game-changer, not just for surgeons, but for the quality of life we can offer our patients."

The ELANA® technology itself is not entirely new; it was refined from a platform originally developed at UMC Utrecht for complex brain bypass surgery, where it has been used in over 1,000 patients since receiving CE marking and FDA clearance over a decade ago. This long history provides a foundation of trust in the core laser technology as AMT Medical brings the re-engineered platform to the much larger cardiac market.

Reshaping the Healthcare Bottom Line

Beyond patient benefits, AMT Medical's innovation carries significant economic implications. The company's internal health-economic assessment, based on benchmark data from major CABG literature, projects that the technology could reduce direct hospital costs related to bypass surgery by 35-50% at scale.

These savings are not merely theoretical. They are driven by the tangible benefits of minimally invasive approaches: shorter ICU and hospital stays free up bed capacity, fewer complications reduce the need for costly interventions, and a standardized procedure can potentially shorten operating room time. While the adoption of new technologies, particularly robotics, involves high upfront capital costs, a device that makes these platforms more efficient and widens their applicability can dramatically improve the return on investment for hospitals.

In a world of strained healthcare budgets and growing patient backlogs, such efficiencies are critical. By tackling a key bottleneck in a high-volume, high-cost procedure, the ELANA® system is positioned not just as a clinical improvement but as a strategic solution for healthcare systems looking to deliver better care more cost-effectively.

Strategic Execution and the Path to Market

With strong clinical data now published, AMT Medical is aggressively moving into its next phase of growth. The company, which has raised over EUR 40 million to date, is preparing its submission for CE marking in Europe for both open and MIDCAB procedures. Simultaneously, it is preparing an Investigational Device Exemption (IDE) submission to the U.S. FDA to begin an Early Feasibility Study in collaboration with leading American cardiac centers.

Steering this strategic push is the company’s recently appointed CEO, Geert van Gansewinkel, who brings a formidable track record. As the former CEO of GATT Technologies, he successfully navigated that company through CE marking, FDA approval, and a strategic acquisition by Johnson & Johnson in 2025. His appointment signals a clear intent to execute a robust commercialization strategy.

"Peer-reviewed publication in JTCVS is a defining milestone for AMT Medical," said Mr. van Gansewinkel. "We now have everything we need to take the next steps: CE marking for open and MIDCAB indications, an IDE submission with the FDA... 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.”

The path to market for medical devices is littered with promising technologies that failed to achieve widespread adoption. Many previous attempts at sutureless anastomotic devices have stumbled due to inconsistent patency, technical complexity, or a failure to demonstrate clear advantages over the traditional hand-sewn method. By delivering robust clinical data from a rigorously designed trial and executing a clear regulatory and commercial plan, AMT Medical is strategically positioning the ELANA® system to finally break that pattern and redefine a cornerstone of modern heart surgery.