The US Food and Drug Administration (FDA) was as busy as ever in October, making key regulatory approvalssupervisor various remember and calling out e-cigarette companies that failed to comply with the law.
This, however, is only the tip of the iceberg. Here’s a review of some other big FDA-related stories that have hit cardiology since the latest regulatory overview was published on September 23:
1. FDA approves new heart failure treatment from scPharmaceuticals
scPharmaceuticals has received FDA approval for Furoscix, a new injection treatment for congestion due to fluid overload in patients Chronic heart failure. Furoscix has been designed for home use, delivering an 80mg dose to the patient. It is not indicated for emergency situations or for patients with acute pulmonary edema.
scPharmaceuticals hopes to begin commercializing this newly approved therapy by the first quarter of 2023.
“Congestion due to worsening heart failure is one of the most common causes of hospitalization in patients over the age of 65, and today’s approval of Furoscix represents an important therapeutic advance. for the more than 7 million heart failure patients in the United States who will be able to self-administer equivalent IV diuresis at home,” said John Tucker, president and CEO of scPharmaceuticals, in a Prepared statement.
2. FDA Clears Abiomed’s Impella Low Profile Sheath
Abiomed has obtained 510(k) clearance from the FDA for its Impella Low Profile Sheath, a new device designed to facilitate the insertion and removal of Impella heart pumps. It was specifically designed with the Impella unique access technique in mind, which allows the user to insert an Impella heart pump without the need for an additional access site at the time of the procedure.
According to Abiomed, this new-look sheath reduces the number of steps required to insert an Impella heart pump and minimizes the risk of a patient experiencing a vascular complication or bleeding event.
“Abiomed’s low-profile sheath is a breakthrough technological achievement that will further improve patient outcomes by making it even easier for physicians to insert, manage and remove Impella heart pumps,” said Chuck Simonton, MD. , chief medical officer of Abiomed, in a press release. Prepared statement.