FDA warns Cook Medical on 'nonconformance' issues
October 28, 2014 by Brad Perriello
The FDA today released a warning letter it sent to Cook Medical last month, flagging problems found during inspections of a Bloomington, Ind., plant last summer.
The inspections turned up issues with how Cook accounts for products that are scrapped during the manufacturing process, according to the letter. The Bloomington plant makes vascular implants, intravascular catheters and related systems. Read more
Abiomed jumps on FDA deal for Impella indication
October 30, 2014 by Brad Perriello
Abiomed shares are up sharply this morning on news of an agreement with the FDA on the indication for its Impella 2.5 heart pump, which the company now expects to win pre-market approval in early 2015 without an appearance before an FDA advisory panel.
The federal watchdog agency’s Circulatory Devices panel recommended in late 2012 that devices like Abiomed’s flagship Impella 2.5 device be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol. Read more
Hansen Medical launches 3rd-gen Sensei surgical robot
October 31, 2014 by Val Kennedy
Hansen Medical said it launched the 3rd generation of its Sensei robot-assisted surgery platform, the Sensei X2, after winning regulatory nods in Europe and the U.S.
Hansen said the FDA OK’d Sensei X2 for use in electrophysiology procedures to map the heart’s electrical impulses, using mapping catheters made by Boston Scientific and St. Jude Medical, but does not cover the use of cardiac ablation catheters. Read more
Medtronic wins EU nod for Resolute Onyx stent
November 3, 2014 by Brad Perriello
Medtronic said it won CE Mark approval in the European Union for its Resolute Onyx drug-eluting stent, made using its new CoreWire technology.
The Resolute Onyx devices is based on Medtronic’s Resolute Integrity DES, but uses the CoreWire technique to wrap a cobalt alloy around a denser metal to increase radiopacity and allow for thinner struts, according to a press release. Read more
