On October 1, 2025, a significant milestone was reached for StypCel™ Absorbable Hemostat, as its post-market clinical follow-up plan has officially concluded. This achievement marks an important step for Medprin Regenerative Medical Technologies Co., Ltd. and MDCECRO LLC, the sponsors behind the study. Focused on the neurosurgical application of this hemostatic medical device, the study aimed to validate its real-world clinical safety and efficacy. The results of this follow-up study are poised to impact clinical, quality, and regulatory teams worldwide.
What were the study objectives?
The post-market clinical follow-up plan for StypCel™ was specifically designed to gather detailed insights into its performance and safety in neurosurgical procedures. As required under MDR Annex XIV, the study aimed to confirm that the device consistently meets its intended purpose in real-world clinical environments. Medprin Regenerative Medical Technologies Co., Ltd., the device manufacturer, partnered with MDCECRO LLC to ensure the plan adhered to stringent regulatory guidelines.
Research teams conducted assessments to evaluate key metrics such as time to hemostasis, adverse events, and complications associated with StypCel™. The study also sought to uncover any unforeseen risks or performance variations when applied in hospital settings.
What did the study reveal?
The study findings confirmed the safety and effectiveness of StypCel™ Absorbable Hemostat for its intended neurosurgical use. Key outcomes include:
- High performance in achieving rapid hemostasis during neurosurgical procedures.
- Minimal adverse reactions reported during follow-up periods.
- Strong clinical evidence supporting ease of application and predictable outcomes.
These results align with the manufacturer’s intended purpose of the device and reinforce its status as a reliable tool for surgeons addressing bleeding risks in complex neurological surgeries.
The completion of this study supports regulatory compliance and provides further reassurance for stakeholders within healthcare and medical device sectors.
What does this mean for stakeholders?
The successful conclusion of StypCel™’s post-market clinical follow-up plan offers significant implications:
- Clinicians: Access to further validated product data enhances decision-making in neurosurgical procedures.
- Quality teams: The study results contribute valuable data for quality assurance and post-market surveillance processes.
- Regulatory professionals: Fulfilling post-market follow-up requirements under MDR strengthens compliance and reduces regulatory risks.
Given its proven efficacy in neurosurgical settings, StypCel™ may see broader adoption as part of surgical teams’ hemostatic armamentarium.
FAQ
1. What is StypCel™?
StypCel™ is an absorbable hemostat developed by Medprin Regenerative Medical Technologies Co., Ltd. It is used to control bleeding during surgeries.
2. Why was a post-market clinical follow-up needed?
Post-market studies ensure a medical device continues to meet performance and safety standards in real-world use, as outlined by MDR Annex XIV.
3. Was the study strictly focused on neurosurgery?
Yes, this particular clinical follow-up specifically evaluated StypCel™ within neurosurgical applications.
Conclusion
The conclusion of StypCel™’s post-market clinical follow-up study represents a pivotal achievement in the trajectory of medical device validation. Clinical, quality, and regulatory teams are encouraged to examine the study's findings for insights that might influence future procedural protocols and compliance strategies.
Disclaimer
This blog post is intended for informational purposes only and does not constitute legal advice. Industry professionals should consult authorized regulatory sources for guidance tailored to their needs.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07199439?term=medical+device