• Celera (Alameda, California) reported the presentation of data describing a novel mass spectrometry-based approach to identify and validate circulating protein biomarkers that detect non-small cell lung cancer. A key outcome of the study was the assembly of an immunoassay test for a panel of 6 biomarkers that detected lung cancer with 94% sensitivity and 93% specificity in a blinded analysis. In addition to detecting all stages of lung cancer studied and all major histological subtypes, the panel also accurately distinguished malignant cases from benign lung disease. "We believe these findings present an important development in our efforts to develop a robust method to detect lung cancer using a simple blood test," said Steve Ruben, PhD, VP of proteomics at Celera. "To this end, we have employed a novel mass spectrometry-based approach to finding biomarkers based on discovery from tumor tissues and tumor cell lines rather than from serum directly. This has allowed us to identify a collection of biomarkers which we have subsequently shown to be elevated in the blood of non-small cell lung cancer patients relative to appropriate controls."

• Cianna Medical (Aliso Viejo, California) reported that a new study shows that the SAVI applicator, a small, expandable device inserted inside the breast to deliver partial breast irradiation, carries a low infection risk, a potential complication of such devices. The research also indicates that other complications – such as persistent, symptomatic seromas, pockets of fluid that build with the use of internal radiation devices – may be less likely to occur than with other devices. SAVI, which consists of flexible catheters through which radiation is given, provides customized radiation therapy and minimizes exposure to healthy tissue after a woman has undergone a lumpectomy to remove a cancerous tumor. Radiation specialists sometimes decide to give women internal radiation – a process called brachytherapy – with the goal of giving concentrated doses of radiation to areas of concern while avoiding healthy tissue.

• Ethicon Endo-Surgery (Cincinnati) reported the launch of the Realize adjustable gastric band-C, the newest addition to the Realize portfolio. The company says the Realize Band-C is a new gastric band with a streamlined design that eases placement and has an expanded adjustment range that can accommodate larger patients. The Realize Band-C has the same clinically proven high-volume, low-pressure system as the original Realize Band, Ethicon said, but in addition to its new design, it has a 14% greater stoma adjustment range to accommodate larger patients. The Band-C has a width of 23 mm.

• Lumenis (Santa Clara, California) has introduced a Holmium Laser Enucleation of the Prostate (HoLEP) training simulator and the PolyScope Disposable Ureteroscope, a new flexible scope with enhanced vision and flexibility. Lumenis says there is a body of clinical evidence that shows that HoLEP provides superior treatment outcomes and is durable long-term. The polyscope uses a disposable ureteroscope with a reusable 10,000 pixel fiber optic.

• MiMedx Group (Atlanta) has received FDA clearance for the Parad s Vaso Shield, indicated for use as a cover for vessels following anterior vertebral surgery. The polyvinyl alcohol polymer (PVA) membrane may reduce the risk of associated injury following anterior vertebral surgeries by providing a vessel cover. Protection of veins and arteries is a common issue associated with many types of surgeries. Protection of the aorta and iliac vessels and other important anatomy is particularly important in anterior spine surgery. The Parad s Vaso Shield was designed to help physicians protect vessels following anterior vertebral surgery. The shield is to be used by inserting it between specific anatomy, such as the anterior spine and adjacent aorta or iliac arteries (vessels). The product may be trimmed and fitted easily at the time of use and is sutured into place.

• Percutaneous Systems (Palo Alto, California) reported the introduced the Accordion CoAx stone control device, the newest member of its Accordion family of disposable kidney stone treatment tools. The CoAx is an over-the-wire stone management device designed to simplify and shorten minimally invasive percutaneous kidney stone procedures, called percutaneous nephrolithotomy (PCNL). A method of stone removal that involves passing small endoscopic instruments through the skin into the kidney, PCNL is the treatment of choice for patients with large kidney stones or for those with complex, irregularly shaped "staghorn" stones. During the PCNL procedure, the Accordion device is deployed in the upper portion of the ureter, a tube that carries urine from the kidney to the bladder. The low-profile Accordion CoAx device is placed over a guidewire, and once in position, forms a proprietary multi-fold, 15 millimeter diameter film occlusion that conforms to and fills the ureter in order to prevent the migration of stone fragments further down in the ureter during the fragmentation procedure.

• Telesso Technologies (Sydney, Australia) said that Miami Children's Hospital is the first site to enroll patients in a head-to-head trial evaluating its FDA-approved guide wire-assisted peripheral IV catheter vs. the industry's gold standard device for peripheral IV placement. Telesso's catheter is placed into the peripheral vein in the arm, below the elbow and is typically passed up inside the vein to a length of 2 to 3 inches. Telesso's guide wire-assisted peripheral IV catheter device uses a retractable nitinol guide wire system that is believed to enable easier IV access, reduce common safety risks, significantly lessen patient pain and discomfort, and provide cost savings to facilities by lowering administrative costs associated with failed IV starts. Telesso said it believes this catheter device is the "first clinically meaningful advancement in peripheral IV access since automatic needle retraction catheters and addresses significant unmet needs in peripheral intravenous access."

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