Stratasys Announces Enrollment is Now Open for 3DHEART Clinical Study on Effects of 3D Printed Heart Models in Pre-Operative Planning

Clinical study supported by Stratasys Corporate Social Responsibility
(CSR) program

MINNEAPOLIS & REHOVOT, Israel–(BUSINESS WIRE)–Stratasys
Ltd
. (Nasdaq:SSYS), the 3D printing and additive manufacturing
solutions company, 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.


The study is being led by physicians from New York-Presbyterian/Morgan
Stanley Children’s Hospital, Children’s Hospital of Philadelphia,
Children’s National Medical Center, and Phoenix Children’s Hospital with
up to 20 additional sites in the US. The study will focus on pediatric
congenital heart patients requiring complex two-ventricle repair. The
primary endpoint being studied is cardiopulmonary bypass time with
secondary endpoints including the prevalence of surgical complications
(morbidity), mortality, and physician assessment of utility. The study
is being managed by OpHeart,
a 501(c)3 nonprofit organization whose mission is to improve the odds
and outcomes for children born with life-threatening heart defects.

“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,” said Dr. Yoav Dori, Pediatric Cardiologist, Children’s Hospital
of Philadelphia. “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.”

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 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,” said
Scott Rader, General Manager, Healthcare Solutions, Stratasys. “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 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.”

“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,” said Arita Mattsoff, VP Public Relations &
Thought Leadership and Responsible for CSR at Stratasys. “3DHEART is a
perfect example of this kind of initiative, leveraging advanced 3D
printing applications to potentially improve surgical outcomes.”

“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.

For more than 25 years, Stratasys
Ltd
. (NASDAQ:SSYS) has been a defining force and dominant
player in 3D printing and additive manufacturing – shaping the way
things are made. Headquartered in Minneapolis, Minnesota and Rehovot,
Israel, the company empowers customers across a broad range of vertical
markets by enabling new paradigms for design and manufacturing. The
company’s solutions provide customers with unmatched design freedom and
manufacturing flexibility – reducing time-to-market and lowering
development costs, while improving designs and communications. Stratasys
subsidiaries include MakerBot and Solidscape, and the Stratasys
ecosystem includes 3D printers for prototyping and production; a wide
range of 3D printing materials; parts on-demand via Stratasys Direct
Manufacturing; strategic consulting and professional services; and the
Thingiverse and GrabCAD communities with over 2 million 3D printable
files for free designs. With more than 2,700 employees and 1,200 granted
or pending additive manufacturing patents, Stratasys has received more
than 30 technology and leadership awards. Visit us online at: www.stratasys.com/medical
or Stratasys
Medical Blog
, and follow us on LinkedIn
Healthcare Showcase
.

Stratasys is a registered trademark of Stratasys Ltd. and/or its
subsidiaries or affiliates.

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