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ST. PAUL, Minn.–(BUSINESS WIRE)– St. Jude Medical, Inc. (NYSE:STJ – News), a global medical device company, today announced it has received European CE Mark approval for its ILUMIEN™ system, the first integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform. The combined system offers physicians advanced physiological and anatomical insight to improve the diagnosis and treatment of coronary artery disease.

The ILUMIEN system features the St. Jude Medical PressureWire™ Aeris, a wireless interventional tool that measures FFR to evaluate the severity of blood flow blockages in the coronary arteries, and the St. Jude Medical C7-XR™ OCT diagnostic imaging technology with Extreme Resolution™, a first-to-market intravascular imaging technology that allows physicians to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies. Combined, the two technologies enable the optimization of percutaneous coronary intervention (PCI) by assisting physicians in identifying culprit lesions responsible for ischemia (coronary narrowings responsible for significantly obstructing the flow of blood to a patients’ heart muscle) and by providing physicians with precise measurements of lesion dimensions and vessel size and structure.

“The ILUMIEN system provides me and my colleagues with an easy-to-use, flexible solution that combines OCT and FFR technology on one system,” said Dr. Evelyn Regar, M.D., Ph.D., FESC, Associate Professor, Department of Interventional Cardiology Thoraxcenter in Rotterdam, Netherlands. “Having these two cutting edge technologies together is a welcome advancement for therapy guidance, allowing me to choose the right tools for each patient situation.”

Additionally, the St. Jude Medical ILUMIEN system features the Wi-Box™, a wireless device that enables the ILUMIEN system to receive data (aortic pressure readings) from the catheterization lab wirelessly. The Wi-Box allows physicians and staff a completely cable-free FFR solution, combining the ease of use of a built-in system with the cost efficiency of a mobile platform.

“Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “We believe integrating these technologies is key to providing physicians a simplified, streamlined option for the diagnosis and treatment of patients with coronary artery disease.”

The C7-XR System with the C7 Dragonfly™ Imaging Catheter and the PressureWire Aeris were launched in Europe in 2009.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries as measured by PressureWire Certus and PressureWire Aeris. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients’ heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.

Current data show that physiological assessment using FFR prior to placement of coronary stents helps physicians better optimize clinical outcomes by determining which specific lesion or lesions are responsible for a patient’s ischemia. In January 2009, St. Jude Medical announced results from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, a randomized, prospective, multi-center trial. The study enrolled 1,005 patients with multivessel coronary artery disease and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. The 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), such as death, myocardial infarction or repeat revascularization, were reduced by 30 percent for patients whose treatment was guided by FFR rather than by standard angiography alone.

About Optical Coherence Tomography (OCT)

Optical Coherence Tomography (OCT) is a leading imaging technology platform that aids physicians in the diagnosis and treatment of cardiovascular disease. OCT utilizes near-infrared light to create images to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies- such as fluoroscopy and intravascular ultrasound (IVUS). OCT can be especially important for the assessment of stent placement because the high-resolution images show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, optimizing treatment and follow-up strategies.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

The registry is built on Cook’s exclusive online system called OpenDoor℠ — the industry’s first transparent clinical-data management offering for physicians. OpenDoor provides users with the opportunity to review clinical data, benchmark individual results and collaborate with physicians to identify better methods of providing patient care. Physicians and researchers will be able to track outcomes and view community trends within 30 days of entering information. The Resonance registry will also provide a means to collaborate globally across multiple medical specialties, institutions, societies and agencies to evaluate quality patient data.

“We are excited about the registry and pleased to make it available to urologists working with the Resonance Metallic Ureteral stent,” said Jean-Marc Criessel, global leader of Cook’s Urology business unit. “This kind of physician and industry collaboration is what leads to innovative medical products and improved patient care.”

To learn more about the Resonance Registry and how to participate, please contact Corrie Threlkeld at 812.339.2235 ext. 7327 or corrie.threlkeld@cookmedical.com.

About the Resonance Metallic Ureteral Stent

When part of the urinary system becomes blocked by a benign obstruction, the kidneys are unable to drain properly. The Cook Resonance Metallic Ureteral Stent’s unique design relieves this blockage, allows a patient’s urinary system to drain normally and can reduce the frequency of stent changes or the need for debilitating nephrostomy tubes. The stent’s superior compressive and radial strength can withstand up to 25 times more extrinsic compression than plastic stents¹, enabling it to remain patent for up to 12 months.

About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @cookmedicalpr and @CookUro.

“The partnership between Ziosoft and Medicsight should make a compelling match for CT colonography interpretation,” said Perry J. Pickhardt, professor of Radiology at UHW. “CTC will definitely benefit from the pairing of these companies which are two recognized leaders in the advanced visualization field.”

Medicsight received U.S. regulatory clearance for clinical use of its technology in May. Medicsight’s ColonCAD is designed to assist radiologists during their review of CT colonography (CTC – also known as “Virtual Colonoscopy”) images by automatically highlighting potential colorectal polyps (possible precursors to colorectal cancer) on the CT image. The regulatory clearance was supported by a large clinical trial involving 15 radiologist readers who each reviewed 112 patient CT colonography cases. The clinical trial results demonstrated that, when assisted by ColonCAD, radiologists’ accuracy for detecting polyps of all sizes was significantly improved compared with unassisted reading.

“Having recently received U.S. regulatory clearance for our ColonCAD software, we are now entering this important market with strategic partnerships,” said Allan Rowley, CEO for
Medicsight. “Ziosoft’s supercomputing technology provides a powerful alliance with our own state-of-the-art software. Both companies are committed to enabling more confident diagnoses with technology that has passed the scrutiny of regulatory bodies.”

Ziosoft holds numerous clearances for a variety of applications for its supercomputing visualization and functional analytics technology. Medicsight and Ziosoft have been partnering in Europe prior to the U.S. clearance of ColonCAD software.

“Both of our companies provide highly accurate and reproducible image visualization and functional analytics software to aid clinicians in diagnoses and treatment planning,” said Rob Royea, president and COO for Ziosoft. “We look forward to bringing our collective technologies to radiologists and other healthcare providers in support of excellence in patient care.”

About Medicsight PLC

Medicsight plc is a UK-headquartered, research driven, leading developer of computer-aided detection (CAD) and image analysis software for the medical imaging market. Medicsight’s ColonCAD™ software uses an advanced CAD algorithm to analyze CT scans of the colon and automatically highlight suspicious areas that may be indicators of disease. CAD may highlight areas overlooked by the reviewing radiologist, such as small lesions or regions that are hidden from view behind folds in the colon. ColonCAD can be seamlessly integrated with advanced 3D visualization platforms of industry leading imaging equipment partners. The integrated systems provide sophisticated image viewing capabilities, including 3D reconstructed image data, with the added advantage of demonstrating automatic CAD findings to assist clinical end-users in the detection and analysis of disease. For further information, visit www.medicsight.com.

About Ziosoft, Inc.
Founded in 1998, Ziosoft, Inc. is a recognized leader in functional imaging visualization software to benefit clinicians, patients and healthcare specialists. The company’s supercomputing, 3D-4D advanced visualization software provides a wide array of diagnostic tools at any chosen location. With more than 2,000 systems installed worldwide, the Ziostation system from Ziosoft offers state-of-the-art technology to produce superb 3D-4D image quality, helping clinicians to make faster and more confident diagnoses. Ziosoft is a privately held company headquartered in Redwood City, Calif., with locations in Amsterdam, The Netherlands and Tokyo, Japan. For further information, visit www.ziosoftinc.com.

The Technology

The da Vinci Surgical System boasts several unique capabilities, including 3-D visualization and enhanced instrumentation, which allow physicians to perform surgeries through several small incisions that generally range in size from 5 mm to 8 mm in pediatric patients and 8 mm to 12 mm in adult patients.

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Six of the MAKOplasty patients were discharged within a day of the operation since the non-invasive procedure allows for faster recovery as the incision made is smaller than the total knee replacement surgery. Within weeks the patient can resume a regular and active lifestyle.

The procedure can be performed on the knee’s outer, top or inner compartment. MAKOplasty can also be performed as a biocompartmental procedure in the top and inner regions of the knee.

An orthopedic surgeon at Good Shepherd Medical Center, Dr Jordan G Stanley stated that with the MAKOplasty procedure, it is possible for patients to gain a natural knee movement since the procedure retains most of the patient’s knee.

The three-dimensional virtual patient visualization system creates a virtual view of the bone surface and the robotic arm provides the surgeons with visual and acoustic feedback, which helps in a more accurate implant positioning.

Source: http://www.goodshepherdhealth.org/

The new G:BOX Chemi IR6 with its combination of tried and tested lighting, filters and high-resolution 6 megapixel CCD camera allows users to image any combination of commercial IR dyes including LI-COR dyes (IRDye® 680 and IRDye® 800) or Thermo Fisher dyes (DyLight® 680 and DyLight® 800), as well as standard fluorescent and visible dyes in under 40 seconds.

Contained in a safe, light tight cabinet, images are captured by the G:BOX Chemi IR6 using the revolutionary new GeneSys image capture software. The GeneSys software selects the optimal filter/lighting combinations by utilizing its unique database containing imaging conditions for hundreds of commercially available DNA, RNA, protein and IR dyes. Users can then select their preferred protocol and the G:BOX Chemi IR6 will automatically capture a high-quality image of the different dyes.

Laura Sullivan, Syngene’s Divisional Manager stated: “Laser-based scanners can detect IR dyes on Westerns but are expensive and limited in their application because they cannot image many fluorescent or chemiluminescent dyes. This is why we are so proud to introduce our G:BOX Chemi IR6 as an affordable alternative, to the imaging market today.”

Laura concluded: “The G:BOX Chemi IR6 system can generate quality images of multiplex IR Westerns in a fraction of the time a laser-based scanner can, and the system is so versatile it can image all commercial fluorescent, chemiluminescent and visible dyes as well. Scientists looking for leading-edge, cost-efficient technology for analyzing any Western blot would benefit from considering a G:BOX Chemi IR6 system for their laboratory.”