Saluda Medical Unveils CAP24™: The First FDA-Approved Closed-Loop Surgical Paddle Lead

Saluda Medical Introduces CAP24™ Surgical Paddle Lead

Saluda Medical, Inc., a pioneering player in the field of medical devices, has recently expanded its offerings by fully releasing the CAP24™ Surgical Paddle Lead in the U.S., a product that has gained significant attention since receiving FDA approval earlier this year. Effective immediately, this advanced device will be accessible to neurosurgery and orthopedic spine practices nationwide, following a promising initial launch in selected centers.

About CAP24™ and Its Significance

CAP24™ is heralded as the first and only FDA-approved surgical paddle lead that supports dose-controlled, closed-loop therapy, marking a notable advancement in the field of spinal cord stimulation (SCS). This innovative device integrates seamlessly with Saluda's Evoke® System, which is designed to adapt stimulation according to the unique neural responses of each patient. Its low-profile and anatomically contoured design ensures stable placement and comprehensive coverage, attributes that are essential for effective therapy.

Dr. Erika Petersen, a Professor of Neurosurgery at the University of Arkansas for Medical Sciences, emphasizes the revolutionary nature of CAP24™, stating, "It is the first surgical paddle lead designed to support dose-controlled therapy. By providing real-time physiologic feedback, it allows stimulation to be adjusted as neural responses change, thus maintaining consistent therapy delivery."

The potential impact of CAP24™ is far-reaching. It opens doors to spinal cord stimulation procedures which represent approximately 30% of all SCS implants in the United States. As a company, Saluda Medical aims to enhance the quality of life for patients suffering from chronic pain by offering advanced treatment solutions that improve clinical outcomes while minimizing the burden on both clinicians and patients.

The Journey to Full Commercial Release

This full commercial release comes on the heels of a limited market introduction where feedback from healthcare professionals was overwhelmingly positive. In addition to its innovative design, clinicians noted the CAP24™'s effectiveness during preliminary trials, leading to its broad acceptance among medical experts. "Evoke™ Therapy has transformed patient expectations from SCS, previously only accessible through percutaneous leads," underscores Mike Mathias, Saluda's CEO. "This release expands access for patients who require a paddle lead, paving the way for improved treatment options."

CAP24™ is designed to deliver Evoke Therapy, which has shown impressive results in clinical trials. The EVOKE study demonstrated that over 90% of patients who showed a positive response at three months continued to respond at the 36-month mark. This exceptional durability highlights the efficacy of the CAP24™ in managing chronic pain—a key factor for both healthcare providers and patients.

As Saluda Medical forges ahead with its advancements in neuromodulation, it remains committed to providing solutions that adapt in real-time to meet the needs of patients suffering from chronic neurological conditions. This innovative approach not only enhances treatment plans but also reinforces the potential for better overall patient outcomes in a landscape where chronic pain management is critical.

A Bright Future for Saluda Medical

Saluda's mission extends beyond just offering new products. The company is focused on shaping the future of medical technology through continuous development and understanding of neurophysiological responses to treatments. With the introduction of CAP24™, Saluda Medical sets a new standard in the realm of spinal cord stimulation, ensuring that patients receive tailored therapies that can significantly improve their quality of life.

For more insights on Saluda Medical and the CAP24™ Surgical Paddle Lead, interested parties are encouraged to visit Saluda Medical's official website.

Conclusion

Saluda Medical's CAP24™ is a game-changer in the field of chronic pain management. As the first FDA-approved closed-loop surgical paddle lead, it exemplifies the future of personalized healthcare technology. With its widespread availability and anticipated impact on patient care, CAP24™ is set to revolutionize the way chronic pain is treated across the United States.