Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Puritan Bennett™ 840 ventilator’s minimum delivered tidal volume down to 2 mL. This feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams.

The Puritan Bennett 840 ventilator delivers a comprehensive, user-friendly solution offering ventilation for a broad range of patients and acuity levels, from neonates to adults. Multiple therapies of ventilation help clinicians respond with the most appropriate ventilation strategy, including a neonatal continuous positive airway pressure (CPAP) mode, enabling noninvasive ventilation in neonates.

The ability to deliver a minimum tidal volume of 2mL will enable clinicians to safely ventilate the smallest and most critically ill neonatal patients with the Puritan Bennett 840 ventilator. This feature will complement recent enhancements to the Puritan Bennett™ 840 NeoMode™ software, including neonatal CPAP mode and the ability to increase the fraction of inspired oxygen (FiO2) by 20% for up to two minutes during suctioning. An increased FiO2 is necessary to manage adequate oxygenation in patients who are critically ill.

“This FDA 510(k) clearance allows Covidien to make clinicians aware that one device, the Puritan Bennett 840 ventilator, can be used on all patients from newborn to adults,” said Douglas Hansell, M.D., M.P.H., Chief Medical Officer and Vice President, Respiratory and Monitoring Solutions, Covidien. “Now patients, from the smallest neonates in the NICU through adults in the ICU, can receive the clinical benefits provided by the Puritan Bennett 840 ventilator.”

Source
Covidien

Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, announced it has received clearance from the US Food and Drug Administration (FDA) to market its NAVIX™ Access Device. The NAVIX™ Device is an advanced endoscopy system, consisting of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports, designed to enable secure access, dilation and delivery of guidewires for pseudocyst and abscess drainage procedures.

“We are pleased to introduce the NAVIX™ Access Device, the first in a line of revolutionary products under development, based on Xlumena’s Advanced Translumenal Therapy™ technology,” said Michael Allen, President and CEO of Xlumena. “We believe this is an important first step in providing the interventional endoscopist with innovative tools that will enable a broader reach within the specialty and take interventional endoscopy to a new therapeutic level.”

Kenneth Binmoeller, M.D., Medical Director at the Interventional Endoscopy Center at California Pacific Medical Center in San Francisco, Calif. added: “Xlumena has accurately identified some of the technical challenges, the interventional endoscopists are struggling with, and is developing simple, elegant solutions with products such as the NAVIX™ Access Device.

Xlumena will initially make the NAVIX™ Access Device available to a select number of interventional endoscopy centers across the US. The clearance follows the Xlumena AXIOS™ translumenal gallbladder stent and delivery system receiving a humanitarian use designation by the FDA. FDA clearance for the AXIOS™ stent and delivery system is pending.

Xlumena will host a Tech Suite at the Digestive Diseases Week (DDW) meeting in New Orleans, LA on May 2-6, 2010 to showcase the NAVIX™ and other Advanced Translumenal Therapy™ platforms to invited partners and physicians.

Source: Xlumena, Inc