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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - MITrep (Automated mini-invasive surgical approach to the treatment of mitral insufficiency)

Teaser

Summary

Stress, malnutrition, alcohol use disorder and the growth of the geriatric population are factors weighing on the prevalence of heart conditions worldwide. Among these pathologies, mitral valve insufficiency (or mitral regurgitation) affects 10% of the population aged above 75 in both Europe and the US . It is characterized by the leaking of blood out of the valves, which normally ensure its one-way flood through the heart. Blood goes from the heart\'s mitral valve from the left ventricle to the left atrium.

In its moderate form (3% in children, 19% of the population between 50 and 60, 80% patients aged 80+), it causes chronic fatigue and shortness of breath as well as palpitations or racing heart rate that impair active life. But if the amount of leaking blood is severe (10% of people above 75), the patient dies within 5 years from sudden deaths (5 to 6% of the patients each year, approximately 18,000 people).

Mitral Insufficiency (MI) is the second most common valvulopathy in Europe. In the world 22 million of persons was affected by this disease in 2015, this figure will reach 37 million by 2030 that is a raise of 65 %.

Mitral insufficiency is treated with open heart surgery (300,000 surgeries per year in the EU/USA) and on bypass followed by intensive care, which is a hardly bearable roadmap for fragile patients. Therefore, 50% of the patients above 75 are tagged inoperable because of their age . Less invasive repair and replacement procedures (annuloplasty, transfemoral surgeries) have been tested but they all have resulted in additional problems for the patient (such as the improper sizing of the annuloplasty rings, which requires a second surgery). Moreover, all these repair procedures are highly dependent upon the skill of the cardiac surgeon where poorly or inaccurately placed sutures in valves of poor quality may affect the success of procedures.

The surgeons must be highly skilled to perform mitral repair (the valve itself shows variable anatomy and a challenging access). Specialization of the cardiac surgeon is always required, and this is a limiting factor. New accessible techniques must be found to enlarge the number of practitioners able to perform mitral repair, and to answer an unmet need: the care of todayâ€™s inoperable patients.

In this context, CMIâ€™nov has developed MITâ€™rep (going for MITral repair), the first mini-invasive automated surgical device that goes directly to the mitral valve with no trial and error to affix a leak-preventing ring onto the valve with robotized movements.

Work performed

The objectives of the SME Instrument phase 1 project, obtained in 2018, were to perform:

1/ The technical feasibility study, including:
Tests on a simulator in-house: Daily ring implantation tests at beating heart on dead hearts of animals. Reach further robotization level regarding the three surgical actions during operation. Test of the robustness of the device over time. Video-controlled, live monitoring in-situ and recording video/tutorials to service the training to the beta end-users.
Criteria of success: successful implantation of eight 200gr nitinol sutures with a resistance of Â±50gr.

Validation of the feasibility during study on animals (80kg pigs): One animal is implanted with MITâ€™rep during a pilot study. CMIâ€™nov watches the behaviour of the device in a living body and performs a histology study. This study is followed by a larger-scale implementation of six pigs to replicate these results.
Criteria of success: the animal can live with the device with a well-fixed ring. Authorization to test the device on human beings in a multi-centric study is granted.
Before to proceed to this critical stage of the animal trials, CMIâ€™nov team had to schedule trials at beating heart on simulator with dead heart of sheep or veal to test the navigation through the chordae and the fixation in according to the â€œsupport against supportâ€ system. Further to these trials MITâ€™rep underwent major modifications described in the further chapters.

2/ The economic viability assessment and Business Plan including the following work: Market study on targeted geographical areas. User and stakeholder survey to identify the early adopters and the strategic partners. Setting up the patent and IP strategy. Costs analysis on the different phases: development, pre-industrialization/certification, commercialization. Analysis of return on investment. Engaging stakeholders.
Criteria of success: Operational plan enabling to make the financial forecasts.

Final results

The patented device uses the transapical approach, meaning the surgeon makes a small incision in the intercostal space to deliver and fix a textile ring (polyester) via a catheter through the apex of the heart. Once the ring is anchored with nitinol sutures, the mitral valve returns to normal activity. No heavy post-surgery effects are expected.

MITâ€™repâ€™s design and robotized use make it accessible to surgeons, who are not necessarily mitral valve specialists.