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Covidien (COV) Receives FDA 510(K) For Idrive Ultra Powered Stapling System

 August 28, 2012 07:46 AM
 


(By Balaseshan) Surgical device maker Covidien plc (NYSE:COV) said it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iDrive Ultra powered stapling system.

The new stapling system has fully powered, reusable, battery-operated endoscopic surgical stapler. The system will be available in the U.S. beginning in the fourth quarter of 2012.

Powered stapling technology took a big step forward in 2009, as Covidien acquired Power Medical Interventions (PMI) and its iDrive powered stapling technology. Covidien enhanced the iDrive powered stapling system to improve performance in the surgical setting, building on the technology pioneered with older models.

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The new iDrive Ultra system, which features one-handed push-button operation and unlimited articulation, eliminates the need for manual firing force and improves maneuverability, compared with traditional endomechanical staplers.

The iDrive Ultra system is the second offering in Covidien's line of powered stapling devices and the first that is compatible with the company's entire portfolio of Endo GIA reloads with Tri-Staple technology for use in laparoscopic and open surgical procedures.

The iDrive Ultra system combines the precision and control of a powered device with proprietary Tri-Staple technology that provides less stress on tissue during compression and clamping, potentially greater perfusion into the staple line and the ability to manage tissue variability.

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The iDrive Ultra powered stapling system is designed for multi-patient use, thus streamlining operating room inventory management, and offers an environmentally friendly benefit by reducing medical waste.

"Laparoscopic surgery can be an exceptionally labor-intensive endeavor that requires a high level of accuracy within a very restricted anatomical space. The iDrive Ultra powered stapling system will enable surgeons to operate through restricted anatomical space with greater precision, compared with traditional endomechanical staplers," said Paul Hermes, Vice President, Chief Technology Officer, Covidien Surgical Solutions.

COV closed Monday's regular session down 0.13% at $55.55. The stock has been trading between $41.35 and $57.86 for the past 52 weeks.

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