The U.S. saw seven severe catheter-based device recalls in 2023, according to the FDA's medical device recall database. The agency in 2023 tagged 61 medical device recalls as Class I — the most serious level. For comparison, the FDA recalled 60 devices in 2022, of which four were related to catheter-based devices. Last year, the most serious … [Read more...] about The worst catheter-based device recalls of 2023
abiomed
Abiomed wins FDA nod for Impella ECP pivotal heart pump trial
Abiomed (Nasdaq:ABMD) announced today that the FDA approved the version of Impella ECP for its upcoming pivotal trial. Danvers, Massachusetts-based Abiomed enrolled the first two patients in its trial following approval. Dr. Amir Kaki, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, led the procedures. Get … [Read more...] about Abiomed wins FDA nod for Impella ECP pivotal heart pump trial
FDA clears Impella low-profile sheath from Abiomed
Abiomed (Nasdaq:ABMD) announced today that it received FDA 510(k) clearance for its Impella low-profile sheath. Danvers, Massachusetts-based Abiomed designed its sheath to maintain the same inner diameter as the existing 14 French (Fr) sheath used for Impella CP placement. However, the new sheath reduces the outer diameter by nearly 2 Fr. The … [Read more...] about FDA clears Impella low-profile sheath from Abiomed
First patient in the world implanted with Abiomed Impella BTR heart pump
Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study. The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago. Impella BTR is a forward … [Read more...] about First patient in the world implanted with Abiomed Impella BTR heart pump
FDA grants breakthrough device designation for Abiomed’s Impella ECP heart pump
Abiomed (NSDQ:ABMD) this week announced that the FDA has granted breakthrough device designation for its Impella ECP expandable percutaneous heart pump. Danvers, Mass.-based Abiomed designed the Impella ECP heart pump to be compatible with small-bore access and closure techniques. It measures 3 mm in diameter when inserted and removed from the … [Read more...] about FDA grants breakthrough device designation for Abiomed’s Impella ECP heart pump
FDA grants PMA to Abiomed’s next-generation Impella RP
Abiomed (NSDQ:ABMD) announced today that the FDA granted premarket approval (PMA) to its Impella RP with SmartAssist. Danvers, Mass.–based Abiomed received PMA for the Impella RP right heart pump with SmartAssist as a safe and effective treatment for acute right heart failure for up to 14 days, according to a news release. Get the full story at … [Read more...] about FDA grants PMA to Abiomed’s next-generation Impella RP
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 … [Read more...] about FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
How innovative pump designs power intelligent balloon catheters
The next generation of intelligent balloon catheters depends on novel designs of ball-screw-driven pumps. Bruce Gretz, Steinmeyer Balloon catheters have long seen widespread use in cardiovascular applications. One of the first, decades ago, was intra-aortic. A balloon was implanted into the descending aorta and pressurized via a percutaneous … [Read more...] about How innovative pump designs power intelligent balloon catheters
