ANALYSIS
LDR opens new and expanded global headquarters in Austin, Texas - December 2011
LDR, a medical device company providing zero-profile technology for both non-fusion and fusion spine applications, announced that it has moved into a new, larger office facility. The new office complex increases LDR’s presence in Austin, Texas, US and more than doubles the previous office and warehouse space utilised by the company. Located in one of the fastest-growing quadrants of the Austin area, the new facility was designed and constructed to specifically meet LDR’s needs as a medical device company and also features significantly expanded training capacity for surgeon customers and sales professionals.
Christophe Lavigne, President and CEO of LDR, comments, “Over the last few years we have quickly outgrown the space we have held since opening the U.S. office in 2005 and it is critical that we have an infrastructure capable of supporting our rapid growth in the U.S. and around the world. In addition, offering an outstanding work environment will help us to attract top talent to our growing Austin medical device workforce. As a company we are focused on ensuring that our organisation and our facilities are of the highest quality and capable of supporting our current and future operations, and our strengthening position in the U.S. market.”
Mr. Lavigne continues, “Looking forward, LDR will continue to introduce innovative products into the global spine markets. In addition to the anticipated U.S. approval of the Mobi-C® Cervical Artificial Disc, we will be introducing several new products over the upcoming twenty four months for both thoracolumbar and cervical applications. In addition, an expanded U.S. presence will allow us to better partner with our international offices in France, Germany, China, Korea, Brazil and elsewhere.”
LDR was founded in 2000 by partners Christophe Lavigne, Hervé Dinville and Patrick Richard in Troyes, France. Currently headquartered in Austin, TX, LDR has experienced rapid growth through product portfolio expansion and an increasingly global presence. LDR develops implantable spine devices and instrumentation designed to support the clinical goals of surgery while making procedures easier to perform. More information is located at www.ldrholding.com.
Minimising risks of mismatching spinal, epidural and regional devices with incompatible connectors - December 2011
The National Patient Safety Agency (NPSA) has issued a Rapid Response Report for NHS organisations in England and Wales, aimed at ensuring that effective controls are in place to minimise the risk of mismatching spinal, epidural or regional devices with incompatible connectors.
Spinal, epidural and regional devices, with non-luer compatible neuraxial connectors, that will not connect with intravenous equipment, are being placed on the market by industry in response to the NPSA Patient Safety Alert issued in 2009. This latest Rapid Response Report provides additional guidance to the Patient Safety Alert.
Although the use of these devices will reduce the risks of wrong route errors, it is essential that effective controls are in place to minimise the risk of mis-selection and supply of devices with incompatible connectors. Mis-selection can cause delay in clinical procedures and in some circumstances could result in harm to patients.
The Rapid Response Report asks all organisations in the NHS and independent sector that use spinal, epidural and regional devices to:
· Alert healthcare staff who order, receive, transport, restock and clinically use spinal, epidural and regional devices of the risk of mis-matching connectors.
· Check current stocks of spinal, epidural and regional devices and ensure these devices are compatible.
· Amend written distribution and clinical procedures to confirm the identity of the connectors used in devices.
· Use procedure packs to ensure that all the devices required for a specified procedure are compatible and readily available.
· Ensure clinical staff check all devices required for a procedure are fitted with the same connector design before commencing the procedure.
Professor David Cousins, Head of Patient Safety Medication Practice and Medical Devices, National Patient Safety Agency, said:
“The NPSA has recently received details of a patient safety incident, where a spinal needle with a neuraxial connector was supplied and used in error when a device with a Luer connector was required. The labelling and packaging of the two devices with Luer and neuraxial connectors, from the same manufacturer, looked very similar in their appearance.
“NHS staff should be made aware of the risk of mismatching connectors. The actions in this Rapid Response Report provide essential controls to prevent delay to clinical procedures, averting adverse outcomes.”
The National Patient Safety Agency (NPSA) has alerted devices manufacturers of this risk and will promote the need for safer design of labelling and packaging to clearly indicate the type of connector used in these devices.