Background

Medical device manufacturers–with the involvement of notified bodies–must declare compliance, for both new and established products, to the applicable requirements of the EU MDR. EU MDR post-market requirements involve the continuous collection of clinical data, and evaluation of safety and performance after a device has been placed on the market. Manufacturers are required to develop and implement a post-market clinical follow-up (PMCF) plan as part of their post-market surveillance (PMS) program. PMCF is the proactive collection of clinical data, and activities may include:

• Prospective or retrospective clinical studies
• Patient registries
• Surveys
• Analysis of real-world data

Project Description

3Aware engaged with Cook Medical, a major U.S.-based medical device manufacturer with an extensive portfolio developed over 60+ years, on a PMCF project for their Instinct PlusTM device. The device is used in the gastrointestinal tract, for the purposes of: 1) endoscopic marking, 2) hemostasis for mucosal and submucosal defects less than 3 cm, bleeding ulcers, arteries less than 2 mm, polyps less than 1.5 cm in diameter, diverticula in the colon, and prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, 3) anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4) as a supplemental method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively, and 5) anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

Previously, Cook Medical executed a PMCF activity for the InstinctTM Endoscopic Clipping Device via a retrospective chart review. For this round of PMCF activity with the second generation InstinctTM device, Cook Medical utilized the 3Aware aiSurveillance platform to gather clinical data covering a wide breadth of uses.

Introduction to aiSurveillance

aiSurveillance is a new approach to post-market surveillance combining data science and clinical science, developed specifically for the MedTech industry. aiSurveillance software integrates real-world data (RWD) sources, such as EHRs and inventory management systems. The software processes vast amounts of patient data, transforming the data into easily assessed patient outcome information from which reliable and actionable insights can be discovered. These RWE insights, available to MedTech at a fraction of the time and cost of other RWE methods, drive timely clinical and strategic product decisions.

Results & Conclusion

With the aiSurveillance platform, along with 3Aware clinical scientist support, the Cook Medical team successfully collected data on each indication. 3Aware aiSurveillance uncovered safety and performance data consistent with published prospective studies. Access to unstructured physician notes provided clarity regarding potential complications, adverse device effects and performance failures and prevented misidentification of indication.

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