Wednesday, June 14, 2023
PECA Labs, a medical device company focused on developing durable polymeric cardiovascular devices, has successfully performed the first-in-human implantation of the MASA Valve. This valve is designed specifically for pediatric patients and serves as a polymeric valved conduit for pulmonary valve reconstruction. The MASA Valve has received regulatory approvals, including Humanitarian Use Device (HUD) and Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). PECA Labs has initiated enrollment for the MASA Valve Early Feasibility Clinical Study (MVEFS) at multiple clinical sites in the United States. Their goal is to advance the field of cardiovascular medicine through innovative polymeric materials and device designs that provide a durable and lasting solution.
The Children’s Hospital of Philadelphia (CHOP), a renowned pediatric hospital and research institute, has achieved a significant milestone by becoming the first global site to successfully implant the MASA Valve in a pediatric patient. This accomplishment marks a major step forward in PECA Labs' mission to introduce the first polymeric pulmonary valve to the market and improve patient outcomes. The MASA Valve, designed for pediatric use, serves as a polymeric valved conduit for pulmonary valve reconstruction. It has received regulatory approvals, including the Humanitarian Use Device (HUD) designation and Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). CHOP initiated the implantation in a 21-month-old child who had previously undergone surgery using a human tissue valve (homograft) at around one year of age. The homograft had developed severe stenosis and required immediate replacement, which was successfully achieved using a 14mm MASA Valve. Early assessments of the patient have shown promising valve functionality, indicating positive results from the MASA Valve implantation. This achievement brings PECA Labs closer to their goal of enabling pediatric patients to benefit from this innovative technology, with the aim of reducing re-interventions and re-operative procedures.
Artificial grafts and valves play a vital role in the treatment of vascular diseases and disorders in both pediatric and adult populations. Approximately 4,000 children in the United States require pulmonary valved conduits each year. Existing valve implants are typically made from metal, ceramic, or bioprosthetic materials, which can elicit biological responses, lack customization options, cannot grow with the patient, and have limited lifespans of five to ten years. Failed conduits necessitate repeat surgeries and interventions, resulting in substantial costs exceeding $100,000 per patient on average. Moreover, current interventions for failed implants do not address the underlying cause of failure. As a result, healthcare professionals face challenges in providing long-term solutions for pediatric patients with congenital heart defects.
PECA Labs has developed the MASA Valve using entirely polymeric materials to address these limitations. This approach aims to minimize the body's immune response and valve calcification, which often lead to valve failure with biologic valved conduits. The MASA Valve offers enhanced durability and incorporates PECA's proprietary conduit and leaflet membrane, allowing for a wide range of sizes to ensure a precise fit with each patient's unique anatomy. By reducing the need for replacement surgeries and interventions, the MASA Valve has the potential to reduce the risks associated with morbidity and mortality.
Dr. David Morales, executive co-director of the Heart Institute at Cincinnati Children's Hospital and principal investigator in the MASA Valve trial, emphasizes the advantages of the MASA Valve: "The MASA Valve avoids the use of biologic or foreign tissue, which is expected to reduce the risk of calcification, immunity-based rejection, and valve shrinkage. The valve design also aims to decrease the administration of antithrombogenic drugs throughout the patient's lifetime. These factors have the potential to significantly improve patient outcomes and may result in fewer valve replacements over a child's lifetime. If successful, the MASA Valve could offer a substantial advancement in the treatment of cardiovascular congenital heart defects in children and lead to significant cost savings in cardiac care."
Once approved, the MASA Valve will become the only non-biologic option for valve replacement in this critical procedure and aims to be the first fully polymeric valve available in the market.
Doug Bernstein, CEO of PECA Labs, explains the development of the MASA Valve: "In designing the MASA Valve, our goal was to leverage our polymer platform to combine the desirable characteristics of homograft tissue, which reduces the need for antithrombotic therapy, with mechanical valves, which offer improved durability, availability, and resistance to calcification and shrinkage. We then enhanced these features with a novel bi-leaflet design. We are optimistic that the ongoing study will validate our belief that the MASA Valve represents a new gold standard for congenital heart patients."
The MASA Valve Early Feasibility Clinical Study (MVEFS) is a non-randomized trial that plans to enroll an initial group of 10 to 15 patients at up to five sites. Independent assessments of patients will be conducted using echocardiographic analysis of regurgitation and valve function immediately post-operation, at 30 days, six months, and one year, followed by annual assessments up to the fifth year. Data on re-intervention and re-operation will be presented alongside final results and compared with published outcomes from a pivotal trial of a competing device.