Lungpacer Medical Inc. is the most recent company to be accepted into FDA’s Expedited Access Pathway (EAP), a year-old program intended to give innovative devices a regulatory leg-up to speed the path to market. The company announced that its Lungpacer Diaphragm Pacing System had been granted an EAP designation on May 11.

“Our team is thrilled that the Lungpacer DPS was granted EAP status. This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most rapid path to commercialization in order to help our patients,” said Lungpacer CEO Doug Evans.

The pacing system, which has not been approved for sale in any country, uses temporary minimally invasive transvascular nerve stimulation to restore diaphragm strength and endurance in patients who had an ongoing need for mechanical ventilation because their diaphragm muscles atrophied after too long on a ventilator. The treatment could benefit up to 31% of all patients who receive mechanical ventilation, Lungpacer says.

FDA has reviewed 29 products for entry into the EAP program and accepted 17, according to FDA.

The acceptance to EAP means LungPacer will work more closely with FDA reviewers than they would if they had submitted a standard PMA. FDA also offers EAP participants priority review, greater involvement of the device center’s senior management, and the assignment of a specific case manager to follow the device from pre-submission to approval. The program also allows manufacturers to perform less burdensome premarket clinical trials by shifting some data collection to the postmarket phase.

More Qualifiers Than Predicted

The British Columbia-based device-maker now stands as one of a handful of manufacturers to announce their participation in EAP. However, FDA sources confirm the ongoing project has drawn even more interest behind the scenes.

During a recent session at the Food & Drug Law Institute Annual Meeting in Washington, D.C., on May 6 , Murray Sheldon, associate director for technology and innovation at the agency’s device center said “around 20 or 30” devices had been accepted by the EAP program since it launched in April 2015. (See [A#01150413013].)

Agency spokeswoman Deborah Kotz later clarified that, while FDA has reviewed 29 applications for EAP designation, 17 were granted, while the other 12 were denied.

This is higher than the device center’s pre-launch estimate that fewer than 10 products per year would qualify for EAP acceptance. (See Also see "FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program" - Medtech Insight, 23 April, 2014..) Acceptance into EAP does not guarantee device approval.

Before a product can be accepted into EAP, FDA must agree that it is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition; that it might represent a breakthrough technology that provides a clinically significant advantage over existing technology; and that patients would benefit from access to the device because it addresses an unmet medical need. The program is open to both PMA and de novo submissions.

“Devices may meet an unmet need or offer significant improvement to patients’ lives,” Sheldon said at FDLI. “In those cases, we may be able to review submissions with less evidence.”

Cohera Medical Inc.’s Sylys surgical sealant to help patients with gastrointestinal leak was the first product to announce its acceptance to the EAP pathway in June 2015. (See [A#01150615003].)

FDA says it can't release the names of devices accepted to EAP under federal law, but at least five companies have voluntarily announced their participation. In addition to Cohera and Lungpacer, companies that say they have been accepted include PathMaker Neurosystems, for the MyoRegulator PM-2200 system to treat muscle spasticity; ALung Technologies Inc., for the Hemolung Respiratory Assist System to treat acute respiratory failure; and Avita Medical Ltd., which makes the ReCell Autologous Cell Harvesting Device to treat burns.

EAP was established internally by CDRH. It mirrors some elements of the FDA drug center's "breakthrough" pharmaceutical pathway, which was established by Congress in 2012. Congress is considering codifying EAP and potentially expanding it as a "breakthrough medical device" pathway. (See Also see "Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding Debated" - Medtech Insight, 10 March, 2016..)

*Follow Elizabeth Orr at @elizabethjorr

CDRH's Expedited Access Pathway: 17 Devices And Counting

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