The Voll Degradable Shoulder Spacer FIH study has been listed on ClinicalTrials.gov, signaling a potential breakthrough for patients dealing with massive rotator cuff tears. The device, developed by Voll Medical Technologies Ltd., is designed to address this challenging condition with a focus on biodegradability and improvement in patient outcomes.
Set to commence in the near future, the study is not yet recruiting participants as of October 2025. This announcement will likely be of interest to clinical, quality, and regulatory professionals, alongside healthcare providers and medical device investors seeking to stay updated on emerging orthopedic solutions.
What is the study about?
The Voll Degradable Shoulder Spacer FIH (First in Human) study investigates the clinical efficacy and safety of the degradable device aimed at treating massive rotator cuff tears. According to ClinicalTrials.gov, the trial represents a critical milestone in the progression of medical technology specifically designed for musculoskeletal conditions.
Massive rotator cuff tears remain a debilitating and complex condition for patients. Current treatment options, including surgery and physical therapy, do not always offer long-term relief. The introduction of the Voll spacer aligns with growing efforts to offer minimally invasive yet effective solutions to enhance patient recovery.
The study’s commencement will mark an important step in assessing both the performance and the bioresorbable nature of the device, fulfilling regulatory framework requirements outlined in MDR Annex XIV.
What is the Voll Degradable Shoulder Spacer?
The Voll Degradable Shoulder Spacer is a medical device engineered for patients with significant rotator cuff damage. Designed to provide mechanical support while being fully degradable over time, the spacer aims to complement natural healing processes and reduce reliance on permanent implants.
This innovative approach could improve patient outcomes by addressing safety concerns typically associated with non-degradable implants. Voll Medical Technologies Ltd. emphasizes that simplicity in device design, paired with biodegradability, positions the product as an attractive option for clinicians and patients alike.
Key Features:
- Bioresorbable material to reduce long-term complications.
- Aligned with regulatory performance and safety criteria for medical devices.
- Potential for minimally invasive application, focusing on patient comfort and faster recovery.
The device will undergo rigorous testing during the FIH study to ensure both its effectiveness and adherence to clinical safety standards.
Why is this study important?
Regulatory professionals tracking medical device innovation should note the significance of the Voll Degradable Shoulder Spacer study. First in Human trials are a key regulatory phase for bringing novel devices to market. They determine the clinical utility and adherence to safety protocols mandated by governing bodies.
MDR regulations in Europe and similar frameworks internationally place importance on clinical evaluation linked to device performance. As the device enters trial status, agencies and manufacturers alike will need to focus on evidence-based assessments.
Implications for Industry:
- Supports a growing trend of biodegradable medical technologies.
- Promotes interdisciplinary collaboration between clinical developers and regulatory bodies.
- Sets a precedent for other orthopedic innovations utilizing biomaterials.
The trial also represents a movement toward environmentally conscious medical devices, addressing long-term clinical and regulatory objectives.
FAQ
1. Who will benefit from this trial?
Patients with massive rotator cuff tears who may have limited options in traditional surgical or rehabilitative care can benefit from this device.
2. When will recruitment begin?
The study is currently marked as “Not yet recruiting” on ClinicalTrials.gov. Updates on recruitment timing are expected to be announced soon.
3. How does biodegradability help in medical devices?
Bioresorbable materials reduce risks associated with permanent implants, such as infections or need for secondary surgeries, and align with natural healing processes.
Conclusion
The announcement of the Voll Degradable Shoulder Spacer study signals progress in the development of innovative device solutions for rotator cuff tears. For regulatory, clinical, and quality teams, monitoring the experimental outcomes will offer insights into future directions for devices leveraging biodegradable technologies. As the project moves forward, impacted stakeholders should remain informed about recruitment timelines and early data releases.
Disclaimer
This article is intended for informational purposes for healthcare and regulatory professionals. It does not constitute medical, legal, or investment advice. For specific concerns, please consult relevant experts.
For full details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07208448?term=medical+device