9. November 2011 11:54
The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.
Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.
Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.
The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.
Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.
The products are expected to be launched for sale in early 2012.
14. October 2011 15:00
Mobisante has launched its MobiUS SP1 in the US, the world’s first smartphone-based ultrasound imaging system.
The device joins other portable point-of-care diagnostics that have recently entered the mobile health sector, including GE’s handheld visualisation tool Vscan and Siemens' Acuson P10.
The £4,700 MobiUS SP1 is designed for use in foetal, cardiac, pelvic, paediatric, musculoskeletal, peripheral vessel and abdominal imaging, providing the potential for enhanced patient care in any location, even remote areas.
The mobile health technology uses both cellular and WiFi networks, and consists of a Windows Mobile 6.5-based Toshiba TG01 smartphone, an ultrasound probe and computer software.
The manufacturer claims that the system could also be more suitable for use in low-income regions than traditional ultrasound equipment due to its lower operating costs and the increased convenience it would provide for patients.
Mobisante actually received FDA clearance for the device in February 2011, but it took eight months to implement necessary FDA-mandated controls.
The company is exploring the option of making a version of the product for healthcare-specific tablet computers as well.
13. October 2011 14:32
Canon has received FDA clearance for its CR-2 Plus Digital Non-Mydriatic Retinal camera for use in eye diagnostic imaging.
Tsuneo Imai, Senior Director and General Manager of the Medical Systems Division at Canon USA, said that the approval “brings Canon one step closer to improving eye exam efficiency and eventually leading to the early prevention and treatment of vision threatening diseases”.
The medical device features EOS camera technology using 18 megapixels with low-flash intensity, minimising pupil constriction while shortening the time required for taking multiple pictures.
The product’s use of Canon’s Retinal Imaging Control Software (RICS) allows images to be captured, processed and sent to be stored or printed.
7. October 2011 13:26
The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).
The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.
Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”
The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.
Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”
“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.
The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.
BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.
6. October 2011 14:00
US rehabilitation therapy company Bioness has received CE Mark Approval and FDA clearance for its Ness H200 Wireless system for hand paralysis patients.
The advanced wireless hand rehabilitation device uses mild Functional Electrical Stimulation (FES) to help patients to grasp and release objects while performing daily life activities.
The Ness H200 Wireless system aims to improve hand function, increase therapy time and encourage motor recovery in those suffering from hand paralysis resulting from stroke or other central nervous system disorders.
Todd Cushman, Senior Vice President of Global Business Development and Marketing for Bioness, said: “It is well known in rehabilitation that frequency of therapy and training has a direct impact on outcomes. Simply put, the more patients are able to be active and integrate therapy into their day to day lives, the better their outcomes.”
The device consists of three components: a wireless, lightweight stimulation support (orthosis); a small handheld remote that communicates wirelessly with the system; and a clinician’s programmer that allows patient activity tracking.
The company expects the equipment will become commercially available to neurorehabilitation hospitals and centres in the US and Europe, as well as to consumers for home use, later this year.
Based in California, Bioness specialises in neurostimulation devices to restore mobility and independence to people suffering from nerve damage.