MedCAD Achieves 510(k) Clearance for AccuStride System
MedCAD, a leading medical technology company, has successfully gained 510(k) clearance for its innovative AccuStride Foot and Ankle System. This breakthrough paves the way for the availability of patient-specific precision devices tailored for foot and ankle surgeons. With the uniqueness of its design and advanced proprietary software, the AccuStride System enables surgeons to address multiple related pathologies during a single procedure.
Transforming Foot and Ankle Surgeries
The introduction of the patent-pending AccuStride Foot and Ankle System marks a significant milestone for MedCAD as it expands into lower extremity surgery. Known for its expertise in patient-specific cranial and maxillofacial reconstruction implants, the company aims to leverage its innovative capabilities in this new area. Surgeons can now benefit from a customizable solution that adapts to the distinct anatomical requirements of their patients.
Meeting Surgeons' Needs
According to Nancy Hairston, CEO and president of MedCAD, the newly launched patient-matched solution is groundbreaking. Hairston notes the increasing interest from leading orthopedic specialists in foot and ankle surgery who recognize the advantages of MedCAD's 'whole foot' solutions. By utilizing these custom 3-D printed devices, surgeons may experience a reduction in both the frequency and duration of surgical interventions, leading to improved outcomes.
Innovative Device Design
The AccuStride System is meticulously engineered to enhance arthroplasty outcomes of the proximal phalanx and metatarsal regions. It also offers tailored options for Lapidus revisions and cavus foot corrections. Composed of UV-curable acrylate polymers or titanium alloy, the components are designed with expedited delivery in mind, often ready within just five days following the necessary medical imaging and surgeon's design approval. The system is intended for use in patients aged 12 and older, ensuring a broad application for those in need of foot and ankle intervention.
Holistic Approach for Better Outcomes
Hairston emphasizes MedCAD's commitment to providing surgeons with customizable options reflective of each patient's unique anatomy. By integrating advanced planning technologies, the company empowers surgeons to achieve transformative outcomes in their practice. The holistic nature of the AccuStride System recognizes that issues in one area of the foot can lead to complications in other regions, thereby promoting a comprehensive approach to treatment.
About MedCAD
MedCAD is a privately held medical technology firm based in Dallas, dedicated to revolutionizing the design and production of patient-matched medical devices. Combining precise imaging with surgical expertise, MedCAD creates individualized medical devices and surgical plans specifically for cranial defects, oral surgery, and reconstructive procedures. Every device is custom-made in collaboration with the respective surgeon, streamlining complexities in surgery and significantly improving patient outcomes throughout their recovery journey.
Frequently Asked Questions
What is the AccuStride Foot and Ankle System?
The AccuStride Foot and Ankle System is a 510(k) cleared medical device designed for foot and ankle surgeries, enabling surgeons to address multiple pathologies in a single procedure.
Who is the CEO of MedCAD?
The CEO of MedCAD is Nancy Hairston, who has been instrumental in driving innovations within the company.
What materials are used in the AccuStride System?
The system is constructed from UV-curable acrylate polymers and titanium alloy materials, ensuring robustness and precision.
How quickly can the AccuStride devices be delivered?
Devices can typically be delivered within five days following receipt of medical imaging and design approval from the surgeon.
What age group can use the AccuStride System?
The system is meant for patients aged 12 years and older, making it suitable for a wide range of individuals requiring foot and ankle interventions.
