Stratasys Opens Enrollment for 3DHEART Clinical Study on Effects of 3D Printed Heart Models in Surgery

Stratasys, the 3D printing and additive manufacturing solutions market leader, today announced enrollment is now open for 3DHEART, an investigator initiated trial. 3DHEART, which stands for 3D Hearts Enabling A Randomized Trial, is a randomized, single-blind clinical trial to study the use of patient-specific 3D printed models in pre-operative planning for pediatric heart surgery. Stratasys is providing in-kind support with printing of the models to be used in the trial.
“Stratasys Direct Manufacturing is honored to contribute to such an impactful study with the potential to revolutionize surgical planning and change patients’ lives for the better”
“This study is incredibly important because it will finally quantify what we know from firsthand experience: 3D printed patient-specific models improve surgery, improve outcomes and result in lower treatment costs. If we can empirically demonstrate this, it will be a game-changer for treating not only children with congenital heart defects, but patients across the board.” Dr. Yoav Dori, Pediatric Cardiologist, Children’s Hospital of Philadelphia.
The study will enroll 400 pediatric patients in total. Stratasys Direct Manufacturing, one of the world’s largest 3D printing and advanced manufacturing service providers, is 3D printing heart models for 200 patients on Stratasys Connex multi-material, full color 3D Printers. These models are based on the patients’ MRI or CT scans and enable the surgeon to evaluate and “practice” on an accurate replica of the patient’s heart prior to actual surgery. The results of these 200 patients are being compared to the results of 200 patients who are being treated without the aid of 3D printed heart models.
“Stratasys’ participation in the OpHeart clinical study is a vital part of our Corporate Social Responsibility (CSR) program, aimed at shaping lives and making a difference by improving medical procedures, equipment, and processes. 3DHEART is a perfect example of this kind of initiative, leveraging advanced 3D printing applications to potentially improve surgical outcomes.” Arita Mattsoff, VP Public Relations & Thought Leadership and Responsible for CSR at Stratasys.
“Stratasys Direct Manufacturing is honored to contribute to such an impactful study with the potential to revolutionize surgical planning and change patients’ lives for the better,” said Greg Reynolds, VP of Additive Manufacturing at Stratasys Direct Manufacturing. “We understand the critical nature of this work and we’ve worked with the study investigators to develop a robust and responsive production process that puts these models in surgeons’ hands in as little as three days.”
“This study is truly extraordinary, in that it is a ‘village’ effort. Doctors have seen firsthand how 3D-printing can save lives, but have not had the resources to quantifiably substantiate heretofore anecdotal evidence. This study will do that. I am proud to work with such an esteemed group of clinicians and industry leaders to improve the lives of children like my daughter, and thank Stratasys for their unwavering support,” said OpHeart Executive Director, Anne Garcia.