Press release

DSM’s Bionate® II PCU and BioSpan® SPU to be used in the ReligaHeart EXT ventricular assist device, developed by The Artificial Heart Laboratory at the Foundation of Cardiac Surgery Development

Exton PA, US, 15 Oct 2014 16:00 CEST

DSM, a global leader in biomedical materials science and regenerative medicine, today announced a collaboration with The Artificial Heart Laboratory at the Foundation of Cardiac Surgery Development (FRK) in Zabrze, Poland. FRK will use DSM’s Bionate® II PCU and BioSpan® SPU in its new ventricular assist device, ReligaHeart EXT.

FRK’s ReligaHeart EXT incorporates two DSM materials in its design, Bionate II PCU and BioSpan SPU. The device benefits from the high flex life characteristics of BioSpan SPU to support constant circulation of blood through the system as well as SAME® (self-assembling monolayer end group) technology, which is incorporated into Bionate II PCU. DSM’s SAME technology enables customized surface characteristics that help address device-specific requirements, in this case long-term implantation. Further, DSM’s polyurethanes are biocompatible and biostable, two important factors in the material selection during design of heart assist devices for cardiac support, towards regeneration or transplant. All three applications require a device to partially reside in the body for a few weeks to several months.

FRK is focused on developing products and technologies for treating heart disease.

“We are very excited to work with FRK on their new cardiac assist device, ReligaHeart EXT,” said Chander Chawla, Director of Biomedical Polyurethanes at DSM Biomedical. “The utilization of our Bionate II PCU and BioSpan SPU in this cardiovascular application will provide the biostability and biocompatibility they were looking for in a proven and trusted implant material.”

“DSM’s Bionate II PCU and BioSpan SPU were a natural choice for use in our ReligaHeart EXT as DSM has a long and successful history of providing biostable polyurethanes for medical device implant applications,” said Roman Kustosz, head of The Artificial Heart Laboratory. “Since our focus is to introduce to clinical practice modern techniques and technologies for heart disease treatment, these high quality materials contributed in creating a best-in-class durable ventricular assist device for long-term applications. We chose DSM due to the excellence of their material properties and exceptional level of service.”

FRK intends to seek initial marketing approval for the ReligaHeart EXT in Europe.

For more information about Bionate II PCU and BioSpan SPU please visit: DSM biomedical polyurethanes.

Foundation for Cardiac Surgery Development

FRK has been developing different heart prostheses and ventricular assist devices for 20 years. FRK was established to put into clinical practice modern methods and techniques for rescuing human life in heart failure, supporting cardiac surgeries, and conducting preventive health care. FRK’s activity focusses mainly on carrying out and financing its scientific research and innovative work related to treating heart diseases, educating medical staff and transfer of technology. R&D activity is interdisciplinary and includes: biomedical engineering, construction of heart prostheses, medical robotics, and tissue engineering. FRK consists of 3 main labs: the Artificial Heart Laboratory, the Bio-Cybernetic Laboratory, and the Bioengineering Laboratory. FRK is a co-founder of POLCAS extracorporeal heart assist system consisting of POLVAD-MEV ventricular assist device and POLPDU-401 drive unit, released for production and clinical practice (over 300 patients (1987-2014); and the new ReligaHeart EXT extracorporeal heart assist system consisting of ReligaHeart EXT ventricular assist device equipped with originally Polish tilting disc valves (Moll type) and ReligaHeart DUO drive unit, currently in clinical trials in 2 cardiac surgery centres in Poland aimed to receive CE marking.

For more information

Kwittken & Company

+1 646 747 7161

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