Stratasys (NSDQ:SSYS) said today it began enrollment for patients in its 3DHeart study, which aims to explore the use of patient-specific 3D printed models in pre-operative planning for pediatric heart surgery.
The 3DHeart study will focus on pediatric congenital heart patients requiring complex two-ventricle repairs, with a primary endpoint of cardiopulmonary bypass time with secondary endpoints including morbidity, mortality and physician assessment of utility.
“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 of the Children’s Hospital of Philadelphia said in a prepared statement.
Minneapolis, Minn.-based Stratasys will print the models to be used in the study, which is being managed by OpHeart, a non-profit aiming to improve outcomes for children born with heart defects.
“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,” OpHeart executive director Anne Garcia said in a press release.
The study aims to enroll 400 patients in total, with printing of hear models for 200 patients provided on Stratasys Connex multi-material 3D printers based on patient’s MRI or CT scans. Results will be compared with the 200 patients who were treated without the 3D printed heart model.
“Stratasys is proud to be part of this historical study which for the first time will provide tier 1 data evidence on the potential benefits of using patient-specific, 3D printed surgical planning models. We are committed to advancing the use of 3D printing for a variety of medical applications, including anatomical models, medical device prototypes, and prosthetic devices. Gathering this kind of data will raise awareness for the advantages our customers report seeing on an individual patient basis, including better planned surgeries with faster recovery times,” Stratasys healthcare solutions GM Scott Rader said in a prepared release.
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