Catch-up: Medtronic Wins CoreValve Stay and Covidien’s Pipeline Recall Gets FDA Class

Two of last week’s news items have moved on a bit over the Easter weekend: Medtronic’s increasingly acrimonious spat with Edwards over the respective companies’ transcatheter heart valve offerings, and Covidien’s recall being graded Class I by the FDA.

FDA Clears Disposable Feeding Tube Placement Under Direct Vision

Covidien plc has gained U.S. FDA 510(k) Clearance for its Kangaroo™ feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing visualization for a procedure that is currently blinded.

Delamination Risk Provokes Covidien Recall of PTFE Coated Vascular Products

Covidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

Barrx Treatment Group Significantly Outperforms Control in Barrett’s Esophagus

Results of a new clinical study into the Barrx RF Ablation platform, acquired by Covidien back in late 2011, say the therapy is effective at treating Barrett’s esophagus. So effective that the trial was stopped and the control group offered the treatment.

FDA Clears Covidien’s Puritan Bennett™ 980 Ventilator

Covidien plc has announced its Puritan Bennett™ 980 ventilator has received U.S. FDA 510(k) clearance. The company says its new acute care ventilator is designed to be simple, safe and smart and to enable patients to breathe more naturally than with conventional mechanical ventilators.

FDA Clearance for Covidien LigaSure™ Maryland Jaw

Covidien has received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition the company has completed all European requirements to CE Mark the product. It expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.

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