Thoracic/Respiratory

On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. Now that recall has been expanded to other iterations of the device because it appears they have been marketed without 510(k) clearance which FDA deems necessary in order to establish their safety and efficacy.

Respironics California, Inc., a division of Philips Healthcare has completed notifying its U.S customers of a voluntary recall of 116 Respironics V60 Ventilators in the country and has confirmed that 33 have already been updated.

Interventional Pulmonology company Pulmonx, has announced that the U.S. FDA has approved its request for an Investigational Device Exemption (IDE) to commence a multi-centre pivotal clinical trial which the company hopes will support a subsequent premarket approval application (PMA) for the Zephyr® Endobronchial Valve (EBV).

Covidien has announced that it is not only recalling all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU), but is in fact discontinuing the products.

As is often the case a company’s voluntary recall has morphed into the FDA Class 1 variety. This time it’s Covidien’s Shiley Adult Tracheostomy Tubes which have reportedly suffered disconnection and leakage.

Covidien has confirmed that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8. This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.

CareFusion has issued an update following its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall, which means the problem constitutes a reasonable probability of serious adverse health consequences or death.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.

Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. VivaSight™-DL comprises a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.

US Regulatory Agency, the FDA has selected Medtronic’s thoracic stent graft development product for inclusion in its early feasibility pilot program.

Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.

Minnesota based Nonin Medical, Inc., has announced FDA 510(k) clearance and commercial release with expanded labelling claims for its Onyx® Vantage 9590 professional fingertip pulse oximeter.

This clever device from ApniCure Inc., gets around the need for a mask in treating sleep apnea, by employing a soft mouthpiece which together with a vacuum created by the device pulls the palate forward and stabilises the tongue. FDA agrees and has cleared the device under its 510(k) regulations.

Covidien told us in March it was to acquire Israeli company superDimension. The deal is now done in a transaction worth $300M plus earnouts.

Zephyr Endobronchial Valve (EBV) therapy guided by Chartis Assessment is effective in a broad range of patients according to a new study, published in the European Respiratory Journal and flaunted by pulmonology company Pulmonx.

Covidien and GE Healthcare will both benefit from their newly formalised alliance, which looks like another example of a device market which is employing what we could call pragmatic synergies to future proof itself.