Pulmonary artery sensor for remote heart failure management nets premarket approval
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Key takeaways:
- The FDA granted premarket approval to Endotronix’s pulmonary artery sensor platform for remote management of NYHA class III heart failure.
- The approval is based on the positive results of the PROACTIVE-HF trial.
Endotronix announced the FDA has given premarket approval to its pulmonary artery sensor system for the treatment of NYHA class III heart failure.
The platform (Cordella) is designed to improve remote HF management by providing daily pulmonary artery (PA) pressures and other data via an implantable sensor, according to a company press release.
The approval was based on the results of the PROACTIVE-HF trial, which were presented at the Technology and Heart Failure Therapeutics (THT) annual meeting. The primary effectiveness outcome was HF hospitalization or all-cause mortality at 6 months compared with a performance goal. The primary safety endpoints were freedom from device- or system-related complications and sensor failure.
As Healio previously reported, remote management of patients with NYHA class III HF guided by the PA sensor exceeded performance goals and exceeded quality of life and functional capacity thresholds compared with historical performance goals.
The platform is designed to allow for seated PA pressure measurements with a handheld reader and a tablet that features secure messaging between the clinical team, patient and caregiver, according to the release.
"This approval is very exciting and has the potential to transform care for HF patients. Endotronix's solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits," Liviu Klein, MD, MS, section chief of advanced heart failure, mechanical circulatory support, pulmonary hypertension and heart transplant at the University of California, San Francisco, said in the release. "PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes."
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