Volume 7, Issue 3, June 2019, Page: 42-51
MP-1™ Polyimide for Medical Devices: 1. Pre Clinical Studies
Peter James Burn, General Orthopaedics, Royal Australasian College of Surgeons (FRACS), Christchurch, New Zealand
Alisa Buchman, Medical MAterials Technology (MMATECH) Ltd., Nahariya, Israel
Simha Sibony, Medical MAterials Technology (MMATECH) Ltd., Nahariya, Israel
Amir Oron, Orthopedics, Kaplan Medical Centre, Rehovot, Israel
Received: Apr. 30, 2019;       Accepted: Jun. 12, 2019;       Published: Jul. 2, 2019
DOI: 10.11648/j.ajbls.20190703.11      View  114      Downloads  37
Abstract
Due to constant increase in human life expectancy, more people require primary and revision total hip replacement surgeries, costing billions of US$ per year. Currently used ceramic on X-linked Polyethylene appears to be the best choice by default, but it still wears. The wear particles generated, are the major cause of osteolysis and joint failure. During 2011-14, leading orthopedic companies suffered global recalls of their MoM hip systems resulting in thousands of revision surgeries. The search continues for new and more durable materials bearing materials. Developments in medical technology have increased the demand for advanced materials due to aging population, advanced medical procedures and contagious diseases. Metals and ceramics are prevalent in the medical industry. However, the unique properties of polymeric materials exhibit potential as better replacements for conventional materials. MMATECH Ltd. has developed a new articulation liner made of a revolutionary material of the Polyimide family, MP-1™, a spin-off of the Aerospace industry. MP-1™ has proved to be biocompatible, heat-resistant, highly crosslinked, combining unusual strength, toughness, self-lubrication, excellent friction and wear durability, as well as resistance to fatigue, creep, impacts and chemicals. These properties lead to longer life span and safer articulating implanted components. MMATECH received the CE and ISO certificates for its MP-1™ Acetabular liner of hip implant based on a pilot clinical study conducted in New-Zealand with excellent 13y follow-up results. Ethical Committee approval was granted for a clinical study of 100 patients in New Zealand. The results of the first 82 surgeries follow-up demonstrated normal blood parameters, no osteolysis, and improved quality of life. The performance of MP-1™ even at 13 years is very promising and is now being applied to younger patients (~ 40 Y old) in view of the retrieval data. Part 1 of this research will summarize the pre-clinical studies while Part 2 will deal with the clinical studies.
Keywords
Polyimide, Wear, Hip Replacement, Implants, Mechanical Behavior, Physical Chemical Properties, Clinical Trial, Biocompatibility
To cite this article
Peter James Burn, Alisa Buchman, Simha Sibony, Amir Oron, MP-1™ Polyimide for Medical Devices: 1. Pre Clinical Studies, American Journal of Biomedical and Life Sciences. Vol. 7, No. 3, 2019, pp. 42-51. doi: 10.11648/j.ajbls.20190703.11
Copyright
Copyright © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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