Author Archives: Patricia Silva PhD

Atrial Flow Regulator Receives FDA’s Breakthrough Device Designation

Occlutech’s atrial flow regulator (AFR) — a cardiac implant — received breakthrough device designation from the U.S. Food and Drug Administration for the treatment of pulmonary arterial hypertension (PAH). Breakthrough status is given to medical equipment that offer significant advantages over currently available options for the treatment of…

Team PHenomenal Hope Provides Renewable Power to Puerto Ricans

The non-profit Team PHenomenal Hope is helping Puerto Ricans with pulmonary hypertension (PH) during the ongoing power outage crisis by providing portable solar panels and battery packs. The power outage was caused by Hurricane Maria, in September 2017, which inflicted significant damage to the island. Recovery wasn’t easy…

Cardiome Shares Updates on Therapies, Including Trevyent for PAH

Cardiome recently shared an update on the development of its therapeutic portfolio, including Trevyent (treprostinil injection) for the treatment of pulmonary arterial hypertension (PAH). Following the U.S. Food and Drug Administration’s (FDA) refusal last year to approve a new drug application (NDA) submitted by Trevyent’s licensor SteadyMed,…

Bellerophon Enrolls First Patient in Phase 2b Trial of INOpulse as Treatment for ILD-linked PH

Bellerophon Therapeutics has enrolled the first patient in a Phase 2b clinical trial evaluating INOpulse as a treatment for pulmonary hypertension associated with interstitial lung disease, or PH-ILD. The trial (NCT03267108) will assess the safety and effectiveness of Bellerophon’s pulsed, inhaled nitric oxide treatment for people with PH-ILD, including…