The FDA's Expedited Access Pathway (EAP) for critical devices is gaining momentum. The 6-month-old initiative has added four devices to its pipeline this month, bringing the number of confirmed devices being reviewed under its auspices to 5. CVRx just announced that its CE-marked Barostim neo neuromodulator to treat heart failure is the latest entrant into the program to accelerate the approval of breakthrough devices.
Minneapolis' CVRx says the designation will streamline the pivotal trial of the device, potentially speeding up approval by one or two years. Entrance into the EAP programs means the FDA is more likely to accept the use of surrogate and intermediate endpoints, as well as the use of fewer subjects, according to the program's guidance document.
"We applaud FDA for creating the EAP Designation. This comes at a critical time for heart failure physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies," said Dr. William Abraham, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, in a statement.
The Barostim neo is implanted underneath the skin near the collar bone. It's designed to reduce the workload of the heart by decreasing arterial resistance via modulation of the natural baroreflex system, which a neural mechanism that helps control blood flow. Neuromodulation is used predominantly to treat pain, and its deployment to the cardiology arena makes the device unique, undoubtedly helping it qualify for the EAP program.
"Barostim Therapy is designed to activate the Baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies," Abraham said in a statement.
CVRx said in a statement that the device is a reversible treatment because it can be turned off and is compatible with implantable rhythm management devices. It may also have applications to treat hypertension and chronic kidney disease, according to the company website, though those conditions won't be studied in the aforementioned clinical trial. However, the device is CE marked to treatment hypertension in Europe and other countries that accept the regulatory distinction.
The EAP program applies to devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions." Examples of previous devices that would meet the condition include the first drug-coated balloon catheter to treat vascular disease.
To be accepted into the program, the device must treat a condition or diagnose a condition for which no appropriate means of diagnosis exists, provide a clinically meaningful advantage over existing technologies, or be in the best interest of patients, the FDA says. In addition, the FDA must approve a device's data development plan prior to inclusion in the EAP program.
There are four other confirmed devices in the EAP pipeline, including three that announced their inclusion this month: a neuromodulator made by PathMaker Neurosystems, a wearable artificial kidney from Blood Purification Technologies, a surgically implanted artificial kidney under development at the University of California, San Francisco, and Cohera Medical's surgical sealant.
AdvaMed successfully lobbied for the inclusion of a more ambitious accelerated device pathway in the 21st Century Cures Act to overhaul drug and device industry regulation. The comprehensive bill easily passed the House, but has yet to come up for a vote in the Senate.
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