How MMI Leveraged Castor to Fulfill MDR Requirements for Their Groundbreaking Microsurgery Robot

Introduction

Founded in 2015, Medical Microinstruments (MMI) is pioneering the field of open surgery, having developed the first teleoperated robotic platform (Symani® Surgical System) for microsurgery. This innovative technology features the world’s smallest wristed micro instruments, designed to enhance precision and control in tiny vessels by scaling down surgical movements (7-20x) and reducing tremor.

Headquartered in Jacksonville, Florida, MMI’s employees are dedicated to providing surgeons with an enabling technology that restores patient quality of life for complex conditions including cancer-related surgical reconstruction and lymphedema surgery. Their groundbreaking technology is being studied by the company and by surgeons around the world. MMI turned to Castor for help with a post market study and challenges they were facing with patient enrollment and data capture.

Overcoming Challenges in Conducting a PMCF Study

As pioneers in their field, MMI faced the challenge of collecting data in an area with very little existing data. Their PRIMO study, a Post-Market Clinical Follow-Up (PMCF) study needed to fulfill EU medical device regulation requirements for a novel technology, was designed to gather clinical data on the safety and efficacy of their robotically-assisted surgical system (RASD), Symani. This system aids surgeons in performing microsurgical procedures such as anastomosis, suturing, and ligation on small anatomical structures including blood vessels, lymphatic ducts, and nerves. The PRIMO study evaluates outcomes for two different surgical areas: lymphedema treatment and free flap surgery. The goal is to monitor the safety and efficacy of the robotic system by assessing the success of lymphatic vessel connections and changes in limb volume (lymphedema) and verifying flap survival in its new location (free flap surgery).

MMI needed a robust platform to support the extensive data collection required for their PMCF study. The platform also needed to be user-friendly to ensure surgeons could easily input data, giving MMI the highest data returns possible. Finally, it had to be globally compliant to meet EU’s regulatory requirements.

• Industry

  Medical Device Companies

• Challenge

  MMI needed a robust, user-friendly, globally compliant platform to support the extensive data collection required for their PMCF study to fulfill EU MDR requirements.

• Solution

  Castor provided the MMI team with a compliant, user-friendly platform that was able to enhance enrollment by over 500% and increase data returns for their study.

• Result

  With increased enrollment and data returns, the successful PRIMO study maintained MMI’s compliance with EU MDR requirements, and also supported their FDA De Novo application - with authorization granted in April 2024.

In Control and Increasing Enrollment

In the fast-evolving medical device field, flexibility and growth are paramount. Castor has enabled MMI to accelerate its mission to advance robotic technology that pushes the limits of open surgery and opens new opportunities for surgeons to restore quality of life for more patients with complex conditions. 

As of June 2024, the total number of participating sites is up to 9 and the total PRIMO enrollments are ~300, surpassing the halfway mark to total enrollments. All sites are enrolling prospective patients, and thanks to the Castor database more than half of the sites are also enrolling retrospective patients. There have been 56 retrospective enrollments to date, significantly increasing MMI’s enrollment rate. Here’s a timeline of events:

• April 2021: 1st participant enrolled with EDC partner
• Dec 2022: 18 participants enrolled with EDC partner
• Dec 2023: MMI Switched to Castor EDC & enrolled >200 participants
• June 2024: ~300 participants enrolled with Castor EDC

In addition to complying with EU Medical Device Regulation (MDR), the PRIMO data supported the FDA De Novo application, avoiding the need for a premarket study in the US. Multiple data cuts and exports answered specific questions, with MMI’s statisticians able to perform analyses on the exported dataset. The authorization from the FDA was granted in early April 2024.

MMI plans to run additional PMCF and prospective studies in the future. Castor is proud to support their research in the pursuit of changing lives!

• Learn more about MMI’s innovative robotic technology for microsurgery

*Clinical indications of Symani vary by geography. For product indications specific to your region, visit www.mmimicro.com/indications.