• Astellas Pharma US (Deerfield, Illinois), a subsidiary of Astellas Pharmaformed by the 2005 merger between Fujisawa Pharmaceutical and Yamanouchi Pharmaceutical, said it has been granted FDA approval for the use of Prograf (tacrolimus) as an immunosuppressant to prevent organ rejection in patients who have received a heart transplant. This is the third organ transplant indication in which Prograf has received FDA approval; Prograf is currently used as therapy to treat the majority of patients undergoing kidney and liver transplants.

• Boston Scientific (Natick, Massachusetts) reported the newest addition to its broad portfolio of vascular access products with the launch of its Super Sheath Introducer Sheath, which has received FDA clearance from the for use in the introduction of interventional and diagnostic devices inserted in the human vasculature. The Super Sheath Introducer Sheath, a tube that is placed inside a vessel during an interventional procedure to help with catheter placement, offers several design enhancements. The smooth wire-to-dilator-to-sheath transition is designed to facilitate insertion, to support ease of entry and reduced vessel trauma. The Super Sheath Introducer Sheath's rotating suture wing and translucent hub allow for efficient operation. A silicone-coated valve and the sheath's smooth inner surface promote easy device passage, and radiopaque markers aid in precise device placement.

• Cardinal Health (Toronto) introduced its Vertebrex system for the treatment of vertebral compression fractures at the Society of Interventional Radiology meeting in Toronto. One of the most notable advancements is the new design of the cement tube, which allows the physician to avoid pressure build-up when starting an injection and reduces the risk of trailing cement behind when the injection is complete. The Vertebrex system also advances bone cement preparation by automatically mixing pre-loaded cement components with a computerized motor, creating a more consistent uniform result each time. Since Vertebrex is a closed system, noxious odors are virtually eliminated and sharps risk associated with the glass ampoule is minimized.

• Cordis (Miami Lakes, Florida) said one-year follow-up data from the largest completed drug-eluting stent registry, consisting of more than 15,000 patients, found that the Cypher Sirolimus-eluting Coronary Stent demonstrates the same level of safety and efficacy in clinical practice as in randomized, controlled clinical trials. The results were published in the March 21 issue of Circulation. Specifically, the e-Cypher Registry found that real-world treatment with the Cypher stent in a wide range of patients — including a large number of patients with diabetes (28.6%) — resulted in low rates in the need for repeat procedures, major adverse cardiovascular events such as heart attack and death, and in-stent blood clots. The e-Cypher Registry is the largest Internet-based post marketingsurveillance registry to be completed of its kind and is designed to assess the safety, efficacy and reliability of the Cypher stent in daily clinical practice.

• Cordis Endovascular (Warren, New Jersey), a division of Cordis, said results from its PROOF study were better than expected at 30-day follow-up, according to data presented at the Society for Interventional Radiology meeting in Toronto. The PROOF study, which monitored patients implanted with its permanent OpteaseVena Cava filter, is a non-randomized, postmarketing surveillance study involving 150 patients at high risk for pulmonary embolism who underwent filter implantation at 11 U.S. sites. The study was designed to monitor the performance of the filter through six months. At one-month, filter migration and filter-related symptomatic thrombosis were observed in one patient each (1% and 0.7%), compared to the expected rates of 2% and 10%, respectively. At six-month follow-up, no new cases of filter migration or filter-related symptomatic thrombosis were observed.

• CryoCath Technologies (Montreal), manufacturer of cryotherapy products to treat cardiovascular disease, said it intends to expand the feasibility stage of its STOP AF trial by enrolling an estimated 15 additional patients. This trial is assessing the company's Arctic Front catheter to treat atrial fibrillation. In addition to Massachusetts General Hospital (Boston) and Mayo Clinic (Rochester, Minnesota), patients in this expanded phase will be treated at St. Joseph's Hospital (Tampa, Florida) and Penrose-St. Francis Health Services (Colorado Springs, Colorado), with the latest version of CryoCath's Arctic Front. Arctic Front's revised design incorporates improvements implemented following the start of the feasibility stage, including two balloon sizes, based on physician feedback from clinical use in Europe and the U.S. As a result of these collective changes, the FDA has requested more patients be treated prior to the start of the pivotal portion of the U.S. investigational device exemption trial. The company said the beta-launch of Arctic Front in Europe continues to progress well, with more than 100 procedures performed. Chronic success data on a substantial number of patients will be presented at the German Cardiac Congress in Mannheim, Germany, later this month.

• CyberMedx Medical Systems (Palm Beach Gardens, Florida), a wholly owned subsidiary of EncounterCare Solutions that provides patient data management, communication, and information systems to the hospital and home care industries, reported that LOX-Stat Digital Liquid Oxygen Content Gauge received FDA 510(k) approval. LOX-Stat is part of the STATus home care division product line and is a replacement contents gauge for the Puritan Bennett Companion line of liquid oxygen tanks. LOX-Stat can replace the existing diaphragm gauge providing digitally accurate contents and battery status information. When LOX-Stat is coupled with the NettCom telephony device the tank information can be transmitted to the STATus Electronic Medical Data Exchange, an Internet-based data management system that provides attached device data management for provider operation which can be interfaced to the STATus Electronic Medical Record.

• Cytyc (Marlborough, Massachusetts), a women's health company, reported that four studies describing a variety of clinical and cost benefits of its ThinPrep Pap Test were published in the April issue of Cytopathology. One study compared ThinPrep Pap Test and conventional cytology results in a Canadian cohort of more than 2,000 patients in each group. The authors report a statistically significant increase in the detection of high-grade squamous intraepithelial lesions (HSIL) in patients screened with the ThinPrep Pap Test compared to those screened with the conventional smear. The study also reported that follow-up results of HSIL and more severe lesions showed the ThinPrep Pap Test group had a higher number of tests confirmed as HSIL or malignant and exceeded the number of confirmed conventional tests by 60%.

• HydroCision (Billerica, Massachusetts) said physicians at Accucare Interventional Pain Medicine (Milltown, New Jersey) reported performing their 100th herniated disc repair procedure using HydroCision's minimally invasive outpatient technique, HydroDiscectomy. HydroDiscectomy uses a high-velocity waterjet to quickly and safely decompress herniated discs. The new procedure may bridge the gap between conservative therapy and invasive open surgery, and can offer an option to patients who have failed conservative treatments and may lead to a reduction in their narcotic pain medication as well, the company said.

• Hypoguard (Minneapolis), a developer of diagnostic products, reported that it has received 510(k) clearance from the FDA to market its Assure Pro Blood Glucose Monitoring System, now available. Designed for multiresident use in long-term care facilities, the system offers qcProGuard, the first of its kind, 24-hour reminder to conduct daily control solution testing. A “Hypo“ warning alerts users of low blood glucose readings and four programmable alarms can be used as test reminders. Assure Pro Test Strips are built using platinum technology and require a small blood sample size (1 uL). The test strip is inserted in the top-of-the-meter port and results are displayed in 10 seconds on a large LCD and an adjustable backlight display. A strip release button for strip disposal eliminates the need to touch a used strip. Assure Pro is designed with ProGrip to help secure a hold on the meter and reduce slipping on surfaces.

• NMT Medical (Boston) reported that results from its MIST (Migraine Intervention with STARFlex Technology) trial will be presented on Wednesday at the American Academy of Neurology meeting in San Diego. MIST is the first prospective, randomized, double-blinded study to evaluate the effect of PFO (patent foramen ovale) closure on migraine headaches. NMT's PFO closure technology was exclusively used in the multicenter clinical trial.

• OpGen Technologies (Madison, Wisconsin), a developer of single molecule DNA analysis technology, reported its plans to develop and commercialize Optical Mapping instruments and disposables for research and clinical microbiology applications. The Optical Mapping system compares DNA isolated directly from microbial cells in clinical samples to a comprehensive database of optical genome maps. The company expects to launch the first system early in 2007. The Optical Mapping system is designed to investigate changes in genome structure, and can be used to study the greater than 99.9% of organisms that have not yet been sequenced.

• Orthovita (Malvern, Pennsylvania) said preliminary results of an ongoing study involving patients with vertebral compression fractures were presented at the Society for Interventional Radiology meeting in Toronto. The purpose of the two pilot investigational device exemption studies, conducted in 20 patients each, was to obtain preliminary information for assessing the feasibility and clinical outcome in using Cortoss, Orthovita's product to treat osteoporotic vertebral compression fractures. Patients in the study were treated minimally invasively with Cortoss using either the vertebroplasty technique, where Cortoss is injected directly into the fractured vertebra, or the kyphoplasty technique, where a balloon is first inserted into the fractured vertebra and inflated to create a void prior to injection of Cortoss. The preliminary study results suggest that patients treated with Cortoss using the vertebroplasty technique show improvement as their Visual Analog Score (VAS) for pain decreased from 73 pre-op to 36 at four days, up to 28 at twelve months. These patients also seemed to show improvement in their Oswestry Disability Index (ODI) as it decreased from 52% pre-op to 42% at one week, up to 23% at twelve months. Similarly, the results suggest that patients treated with Cortoss using the kyphoplasty technique show improvement as their VAS for pain decreased from 78 pre-op to 43 at four days, up to 20 at six months. These patients also seemed to show improvement in their ODI as it decreased from 60% pre-op to 49% at one week, up to 38% at six months.

• Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, reported Central Coding for InForm, a new web-based application that is optimized to work with InForm Integrated Trial Management, Phase Forward's electronic data capture product. Central Coding for InForm automatically standardizes clinical trial data input to provide cleaner data more quickly and efficiently for organizations conducting clinical trials. Central Coding for InForm provides sponsors and data managers with centrally optimized process control; coding-centric workflow; out-of-the-box integration with InForm; advanced dictionary administration; and compliance with 21 Code of Federal Regulations Part 11.

• Siemens Medical Solutions (Malvern, Pennsylvania) reported FDA 510(k) clearance for the MVision Megavoltage Cone Beam Imaging Package. Commercially available worldwide, MVision is part of Siemens' portfolio of Adaptive Radiation Therapy solutions. MVision is a volumetric in-line target imaging solution and the next step in image-guided radiation therapy (IGRT). Designed to work with Siemens' linear accelerators, the system is the first commercial implementation of cone beam technology using a standard radiotherapy treatment beam. MVision makes it possible for the megavoltage source used for treatment to also create a 3-D image of the patient. MVision fully integrates and automates acquisition, reconstruction, registration, assessment, patient positioning and clinical review. MVision does not require an independent imaging source for IGRT, maximizing clinical accessibility and patient comfort and freeing caregivers from performing electromechanical maintenance.

• SoftMed Systems (Burlington, Massachusetts), a provider of document creation solutions, and Nuance Communications (Silver Spring, Maryland), a supplier of speech and imaging solutions, reported that SoftMed will deploy Nuance's Dragon NaturallySpeaking SDK (software developers toolkit) to integrate speech recognition capabilities into its new hosted transcription solution, ChartScript.Com. SoftMed will also continue to use Nuance's Dragon NaturallySpeaking SDK to integrate speech recognition into its document management solutions for both server and PC-based applications. Dragon NaturallySpeaking converts speech into text at up to twice the speed of the spoken word, eliminating the cost and turnaround time associated with the manual transcription of patient notes.

• Synergetics USA (O'Fallon, Missouri) reported that it released its newest electrosurgical product, the Malis Advantage. The company said the fourth generation electrosurgical generator offers improvements in user interface, performance, safety, and convenience over the previous generation of the device.

• Viasys Healthcare (Conshohocken, Pennsylvania) said that its NeuroCare division will introduce its new VCare Connect service today at the American Academy of Neurology convention in San Diego. VCare Connect is an Internet-facilitated, remote service, diagnostic and monitoring tool that was specifically designed to work with Viasys NeuroCare products. In addition to real-time remote communications and service, VCare Connect allows Viasys to deliver system software updates and upgrades. VCare Connect uses security protocols that work in conjunction with the customer's existing healthcare network infrastructure. Remote diagnostic sessions occur over 128 bit SSL encrypted links without requiring the use of a virtual private network connection.

• WorldHeart (Oakland, California), a developer of mechanical circulatory support systems, reported that its next-generation pulsatile left ventricular assist system (LVAS), the Novacor II, has entered a key phase of animal testing on the development pathway toward human trials. The Novacor II LVAS is the only small, bearingless next-generation pulsatile ventricular assist device in development. The blood pump is driven by direct magnetic actuation, eliminating any components subject to wear and promising enhanced long-term durability. The company said it plans to conduct a series of animal implants in this preclinical stage over the next 15 months.