Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted specialty pharmacies in an effort to increase convenience for patients, according to a news release.
The Remunity pump for Remodulin injection is indicated for the continuous subcutaneous delivery of Remodulin in adults greater than 22 years of age.
Remunity’s cassettes contain enough drug for up to three days and arrive from the specialty pharmacy prefilled to eliminate the need for a patient to mix or fill. The water-resistant, small device is programmed using a wireless remote to increase safety and simplicity of use.
“We are excited to bring to market the first subcutaneous pump designed specifically for PAH patients,” United Therapeutics VP of global supply chain & alliance management Beth Rhodes said in the release. “Remunity is a small, discreet pump that delivers Remodulin in prefilled cassettes that are delivered directly to patients, offering significant improvements over current subcutaneous pumps.”
The pump was developed by United Therapeutics in conjunction with Manchester, N.H.-based DEKA Research and Development Corporation.
“The team at United Therapeutics have been relentless in their quest to improve the lives of patients with PAH. The Remunity pump is the next step in their critical mission. Everyone at DEKA is extremely proud to be launching our innovative delivery technology with United Therapeutics,” DEKA founder & president Dean Kamen said. “While the COVID-19 pandemic has been devastating to all of us, the DEKA team has never forgotten that the PAH community is particularly vulnerable. This stark reality, along with the unwavering commitment by the UT team, has continued to energize us to reach this significant goal.
“We are confident that the Remunity pump, particularly with cassettes prefilled with Remodulin, has the potential to improve the lives of the patients who depend on United Therapeutics.”