• DePuy Spine (Raynham, Massachusetts) reported launch of the Vertigraft VG2 TLIF allograft, a new bone product designed to facilitate graft insertion and bone growth during transforaminal lumbar spinal fusion (TLIF) surgery. The allograft is comprised of both cortical bone, which provides strength, and cancellous bone, which can promote osteoconductivity (bone growth). The construct is bullet-shaped for straight-in insertion between vertebrae, and is specially designed for oblique (diagonal) placement across the disc space whether the discs are parallel or lordotic. This allows for a less invasive lumbar fusion technique, as compared to the PLIF technique, that may reduce the risk of muscle or nerve damage. The allograft is made up of two cortical bone planks (3mm each) surrounding a 3-mm plank of cancellous bone at the core. The cortical bone provides biomechanical strength, and holds the vertebral bodies in place while the porous, cancellous core facilitates bone growth. DePuy Spine, a Johnson & Johnson company, makes products to treat spine disorders.

• GE Healthcare (Waukesha, Wisconsin) reported FDA clearance for its Carescape patient data module for mobile patient monitoring. The Carescape features 24-hour capture of patient data and a close-to-the-patient, self-powered design that alleviates common portability constraints. The module ensures that the receiving nurse has a complete monitoring history when a patient arrives. Its design allows it to stay with the patient to capture and store all patient measurements — both standard and specialty. GE Healthcare specializes in medical imaging and information technologies.

• Roche Diagnostics (Indianapolis), in cooperation with the FDA, announced that the Urgent Medical Device Correction issued for CoaguChek PT test strips (UMDC 06-266), used in anticoagulation monitoring, has been addressed and duplicate testing is no longer required for CoaguChek PT Test Strips, lot numbers 560A and higher (e.g., 561A, 562A, …). The potential for erroneous prothrombin time (PT) test results that prompted the UMDC was a result of insufficient active ingredient (thromboplastin) on selected test strips. Fully tested and validated changes have been implemented within the manufacturing process to address this concern. All healthcare professionals performing duplicate testing to confirm results can return to a single test using CoaguChek PT Test Strips (only from lot numbers 560A and higher) to monitor patients on warfarin (anticoagulation) therapy. All patients previously performing patient self-testing may now resume monitoring with CoaguChek PT Test Strips (only from lot numbers 560A and higher). Roche is a research-focused healthcare group in the fields of pharmaceuticals and diagnostics.

• Thoratec (Pleasanton, California) said that it has completed enrollment in the randomized portion of the destination therapy (DT) arm of its pivotal trial for the HeartMate II by enrolling 200 patients on a randomized basis as called for in the trial protocol. The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable left ventricular assist system powered by a rotary pumping mechanism, the HeartMate II is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than pulsatile devices. Thoratec specializes in hemodynamic restoration therapy-developing products to treat cardiovascular disease.

• Welch Allyn (Skaneateles Falls, New York) unveiled the AcuityLink clinician notifier at the National Teaching Institute and Critical Care Exposition in Atlanta. The AcuityLink is a hand-held patient monitoring solution that delivers real-time and historic waveforms, numerics and alarm information directly to caregivers via a wireless PDA device regardless of their location. It allows clinicians to self-assign patients at the beginning of their shifts, customize the type of alarms that are transmitted to the device, and utilize a bidirectional communication system with the Welch Allyn Acuity Central Station. It also has a three-tiered alarm escalation system that sends alarms to the primary caregiver and then will automatically escalate to a secondary clinician if the alarm persists and then to all clinicians on the network if necessary. It also provides audible and visual warnings if the user travels outside the wireless network coverage area, as well as distinct alarm tones for high-level and lethal arrhythmias as well as other vital sign parameter alarms. Welch Allyn makes diagnostic and therapeutic devices, cardiac defibrillators, patient monitoring systems, and miniature precision lamps.

• ZOLL Medical (Chelmsford, Massachusetts) reported receiving FDA clearance for its ZOLL E Series with See-Thru CPR technology. This CPR quality improvement benefit is provided by extracting the "artifact" (unwanted visual aberrations in the electrocardiograph (ECG) signal) caused by chest compressions. See-Thru CPR's processing technology actually extracts the CPR artifact and shows a "filtered" ECG on the defibrillator screen, allowing rescuers to see organized cardiac rhythm without stopping compressions. ZOLL Medical makes resuscitation devices and related software solutions.