St. Jude Medical Inc. (NYSE:STJ) landed CE Mark approval in the European Union for what it bills as the first and only hybrid diagnostic imaging system to combine optical coherence tomography and fractional flow reserve technology into a single platform.
The Ilumien system combines a wireless tool that measures the severity of blood flow blockages in coronary arteries and OCT imaging technology that allows physicians to visualize and measure blood vessels. The device also wirelessly transmits pressure readings from the instrument within the blood vessel to the external monitor.
"Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies," said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division, in a press release. "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."
Sequana Medical, which changed its name from NovaShunt AG last month, announced today that it won CE Mark approval for its low-flow bladder pump, which removes excess abdominal fluid in patients suffering from liver disease.
"This is a major milestone both for our company and for patients with refractory ascites," stated Dr. Noel Johnson, CEO of Sequana Medical. "For patients, the treatment options for refractory ascites have been very limited and carried significant risks and side effects. The ALFApump System offers a new treatment tool which can improve patient quality of life while also reducing hospitalizations. It is a cost-effective solution and we believe over time it will become the preferred option for patients, physicians and payers. We are eager to begin our commercial launch in Europe."
Wakefield, Mass.-based ActiViews Inc. landed clearance from the U.S. Food & Drug Administration for its CT-Guide needle guidance system for lung intervention treatments. The device is an accessory for CT scanners and uses a single-use mini-video camera that attaches to standard interventional instruments. It creates 3D images on a HD flat panel monitor mounted on a mobile workstation to help physicians navigate instruments in relation to the spatial location within the lungs and the desired target.
Guided Therapeutics Inc. (OTC:GTHP) has one last question to answer in its pre-market approval application for the LuViva biophotonic testing platform for detecting cervical cancer. The company, which held initial meetings with the FDA in April, expects no problems in fulfilling the agency’s final request and plans to launch the device in late 2011 or early 2012.
Edwards Lifesciences Corp. (NYSE:EW) announced FDA 510(k) clearance for its EV1000 clinical monitoring platform, which features a touch-screen monitor that displays patient information, clinical targets and alerts.
"We look forward to offering this sophisticated technology to clinicians and their patients in the U.S. and to integrating our current and expanding portfolio of catheters and sensors onto this platform," said Carlyn Solomon, corporate VP of critical care.