Impella Propels Abiomed to 21% Revenue Growth Over Equivalent Quarter Last Year

Buoyed by healthy revenue growth from its Impella in-dwelling heart-assist device, Abiomed has reported a Q3 top line up 21% compared with the same period a year ago. Profits are also up with Q3 GAAP net income of $4.4 million compared to $2.7 million last year.

Medtronic’s Valiant Captivia Stent Graft Now FDA Approved for Aortic Dissections

Medtronic has taken the opportunity presented by this weeks Thoracic Society meeting to announce that it has gained U.S. FDA approval for its Valiant Captivia Thoracic Stent Graft System to be used in the treatment of type B aortic dissections.

Option to Acquire Haibo Technology Signals Abyrx’s Entry into Soft Tissue Hemostasis Market

Abyrx™, Inc., has announced it has entered the soft tissue hemostasis market with a commercial deal with Chinese company Haibo Biotechnology Institute’s (HBI) proprietary resorbable plant-derived soft tissue hemostat technology platform.

IFU Changes Mean Codman Neuro’s TRUFILL® n-BCA Liquid Embolic System Gets Class I Recall Status

Codman Neuro has announced changes to the instructions for use for its TRUFILL® n-BCA Liquid Embolic System. It seems incorrectly mixed product can result in embolization or reflux, which has lead the U.S. FDA to label the company’s medical device correction notice as a Class I recall.

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.

Europe-wide Release for Biotronik’s Passeo-18 Lux Peripheral Vascular Drug-Releasing Balloon

Cardiovascular device company Biotronik is in the news again with the announcement of its release of the Passeo-18 Lux Drug Releasing Balloon (DRB) in all countries accepting CE mark, following recent CE approval.

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