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LEDiR: A Ground-breaking Manufacturing Process to Yield a Unique Prosthesis for Lumbar Endoscopic Disc Replacement

Periodic Reporting for period 1 - LEDiR (LEDiR: A Ground-breaking Manufacturing Process to Yield a Unique Prosthesis for Lumbar Endoscopic Disc Replacement)

Reporting period: 2017-05-01 to 2017-08-31

The LEDIR project aims to design and manufacture a device that will improve the lives of patients with DDDs (lumbar degenerative disc diseases).
To minimize morbidity (related to the surgical procedure as conceived at present) it was necessary to evaluate an alternative surgical pathway, which allowed the positioning of the LEDIR device attenuating the discomforts that could have affected the patient's recovery.
Thank to this new approach the company had been able to realize a disk prosthesis that use a new endoscopic technique.
The company came to the conclusion that in spine surgery it is really important to minimize tissue stress.
During the validation of the process for the achievement of the objective, it was realized that to minimize morbidity (related to the surgical procedure as conceived at present) it was necessary to evaluate an alternative surgical pathway, which allowed the positioning of the LEDIR device attenuating the discomforts that could have affected the patient's recovery. The choice of a lateral surgical approach was therefore identified as necessary to achieve the aforementioned objectives.
Tsunami Medical maintains its intention to use the topic “Accelerating the uptake of nanotechnologies, advanced materials or advanced manufacturing and processing technologies by SMEs” to try to improve the biological/mechanical seal of the device, thus accelerating the functional recovery of the patient. As demonstrated by the in vitro work reported in the Final Report, this path is certainly better than the current golden standards.
As previous LEDIR project was linked to a TLIF surgical technique with, however, several technical issues, the development of the sock device made it possible to Tsunami Medical to redesign LEDIR, maintaining the basics of the idea but enhancing the final result for patient quality of life due to minimizing morbidity and boosting safety.
All the surgical techniques realized since today, a metallic or polymeric dilatation/retraction systems are used; also during endoscopic procedures a metallic tubes that keep the tissue spread for the time required for the surgery are used.
Analyzing the state of the art and the clinical results, and due to own experience in previous cadaver labs, we decided to study a different surgical approach to prevent soft tissue and neural structure damage.
Initially the project was intending to use a trans-foraminal (TLIF) approach to minimize the possible risk, but during the initial study (phase 1) and the numerous cadaver lab realized we decide to adapt use the direct lateral (DLIF) approach, that in the last 5 to 6 years is having a very good result for the lumbar disc surgery. The DLIF approach guarantee a minimal invasive surgery with a very safe surgical access. We realized a new device mimicking a sock made out of nylon/carbon with 2 metallic rings at the extremity. The use of this innovative device will prevent all issues related to long lasting tissue retraction often happening during standard procedure both in Lateral and in Prone position.
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