Exton, PA, November 12, 2014
DSM, a global leader in biomedical materials science and regenerative medicine, today announced results from a recently completed in vivo study conducted in conjunction with University Medical Center Utrecht (UMCU) in The Netherlands. The study, examining the use of woven heart valve structures made entirely out of DSM’s Dyneema Purity® 10 dtex fibers, yielded promising results. A test group of sheep lived for six months without sign of clinical illness after implantation of a prototype heart valve made from woven Dyneema Purity® 10 dtex fibers. During the course of the study, the animals only received aspirin for anti-coagulation.
A multi-year partnership collaboration between UMCU and DSM began in 2012 with the goal of developing and evaluating a prototype of a non-biological supportive scaffold for the minimally invasive treatment of valvular and vascular diseases. Heart valves currently on the market fall into one of two categories. The first classification includes mechanical heart valves, which have lifelong durability, but cannot be used in minimally invasive surgery and necessitates patients maintain an anti-coagulant regimen for the rest of their lives. The second classification is biological heart valves utilizing bovine and porcine tissue, which do not require the need for anti-coagulant therapy and can be used in minimally invasive surgery, but have a limited durability of only 7-15 years, presenting the risk of patients needing secondary surgeries. This market segmentation shows that there is a clinical need for an alternative material that can be used in the design and development of a new type of heart valve that combines the best of both existing types, i.e. one that is biocompatible, durable for over 15 years and can be used in minimally invasive surgery such as TAVI procedures.
Dyneema Purity® 10 dtex fiber enables the creation of minimal profile structures without compromising on high strength, high flex fatigue resistance, low elongation, and tear resistant properties. Because of this and the fiber’s exceptional durability, biocompatibility and processability into structures that can be used in minimally invasive surgery such as TAVI procedures, Dyneema Purity® 10 dtex fiber is a viable material to use in heart valve construction.
“My work with Dyneema Purity® fiber proves that the material’s unique properties have great potential for use in these kind of high-end cardiovascular applications,” said Dr. Paul F. Gründeman, Project Director, Associate Professor of Experimental Cardiothoracic and Vascular Surgery at UMCU and Professor at Beijing PLA Medical School. “Our ongoing and open collaboration with DSM exemplifies both institutions’ commitment to innovation that will benefit medical device makers, physicians and patients around the world.”
“Combining UMCU’s clinical expertise and cardiovascular device testing experience with DSM’s fiber technology and fiber processing expertise made the open innovative partnership a combination of true strengths,” said Dr. Carola Hansen, Director of Biomedical Polyethylenes at DSM. “These study results are additional proof points for DSM to show the medical world what kind of high-end innovation is achievable with Dyneema Purity® fiber.”
To learn more about these study results and DSM’s portfolio of biomedical materials and technologies, visit us at COMPAMED 2014, hall 08a, booth k28.
Dyneema Purity® fibers are available globally.For more information about DSM’s Dyneema Purity® 10 dtex fiber please visit: DSM biomedical polyethylenes.