New eye disorder drug launched in UK

by JoelLane 16. April 2013 16:39

CB011723 Jetrea (ocriplasmin), a drug used to help prevent sight loss through vitreomacular traction (VMT), has been launched in the UK.

The launch by Alcon, a division of Novartis, represents the drug’s first entry into the European market.

Developed by Belgian company ThromboGenics, Jetrea could help to save the sight of over 250,000 patients in Europe.

Alcon has entered into a partnership with ThromboGenics to sell Jetrea outside the US.

The manufacturer has now received two €45m milestone payments from Alcon: one for the drug’s EU approval and one for its first sale in the UK.

Jetrea is currently undergoing NICE appraisal, with guidance expected near the end of 2013.

VMT is a progressive age-related condition in which the vitreous humour becomes too strongly attached to the retina, eventually tearing it.

Administered by a single injection, Jetrea (an enzyme suspension) breaks down the protein fibres that cause traction on the retina. It can prevent damage to the retina or stop existing damage from becoming worse.

The only current treatment is late-stage surgery to repair a damaged retina, but this is often too late to save the patient’s sight.

“The launch of Jetrea in Europe by Alcon so shortly after gaining European approval is testimony of our joint commitment to ensuring patients in Europe have access to this innovative drug as soon as possible,” said Dr Patrik De Haes, CEO of ThromboGenics.

“We expect that Alcon will roll out Jetrea into other European markets in the coming months and are working with our partner to ensure that all the support for physicians, payers and patients is fully in place.”

No Cancer Drugs Fund for Wales

by JoelLane 25. May 2012 11:16

red-dragon-flag1 The Welsh Government has decided not to adopt a Cancer Drugs Fund (CDF), but rather to rely on existing mechanisms to ensure patient access to cancer therapies.

Health Minister Lesley Griffiths said the fund, currently used in England to ensure patient access to non-approved medicines, was at odds with an “evidence-based” approach.

He also claimed that early diagnosis, surgery and radiotherapy were all higher priorities for cancer patients.

Speaking to the All Wales Medicines Strategy Group, Griffiths said: “A Cancer Drugs Fund would not be in the best interests of people in Wales. We already have robust mechanisms in place to ensure access to non-approved medicines is consistent for patients in exceptional circumstances.”

More contentiously, Griffiths claimed: “There is no evidence a Cancer Drugs Fund improves the quality of life or survival rates.” It would undermine the Group’s attempts “to deliver evidence-based advice on new treatments,” he argued.

“The available evidence does show survival is more closely linked to early diagnosis while surgery and radiotherapy are more likely to influence survival, and it is on these issues we should focus.”

The CDF allocates £200m per year to the NHS for 2012 and 2013 to ensure individual patient access to certain non-approved drugs prior to the introduction of value-based pricing at the end of 2013.

Antibiotics can treat acute appendicitis

by JoelLane 11. April 2012 09:00

Pf clinical news Treatment with antibiotics is a safe and effective alternative to surgery for acute appendicitis, according to a new study published in the BMJ.

A meta-analysis of four clinical trials showed that antibiotic therapy achieved a 63% success rate while reducing complications by 31% relative to surgery.

The study concluded that antibiotics should be considered as a first-line therapy for uncomplicated appendicitis.

In cases where appendicitis has led to peritonitis or perforation, surgery remains essential, the researchers said.

Removal of the inflamed appendix has been the standard treatment for acute appendicitis since 1889 – but the study argued that this is based “mainly on tradition rather than evidence”.

The study, by researchers at the Nottingham Digestive Diseases Centre NIHR Biomedical Research Unit, compared the safety and efficacy of antibiotic therapy with surgery as a first-line treatment for uncomplicated acute appendicitis.

It analysed the results of four randomised controlled trials covering 900 adult patients diagnosed with uncomplicated acute appendicitis, of whom 470 received antibiotics and 430 underwent surgery.

Treatment with antibiotics was associated with a 63% success rate at one year, and offered a 31% reduction in risk of complications compared to surgery.

There were no significant differences in length of hospital stay or risk of developing complicated appendicitis between the two patient groups.

The researchers suggested that a ‘wait, watch and treat’ policy could be adopted in patients who appear to have uncomplicated appendicitis, since the benefits of using only antibiotic therapy outweigh the risks.

Antibiotic therapy is “a safe initial therapy for patients with uncomplicated acute appendicitis” and “merits consideration as a primary treatment option for early uncomplicated appendicitis,” they concluded.

However, early surgery would remain the standard treatment for patients with clear signs of perforation or peritonitis.

Medtronic launches spinal stabilisation device

by emma 8. November 2011 16:26

Medtech Product News

Medtronic has launched its T2 Altitude expandable corpectomy device for spinal stabilisation and correction worldwide.

The expandable vertebral body replacement cage features a self-locking mechanism that removes the need for placing a set screw during surgery, using bone graft to create contact to encourage fusion with the device.

Doug King, Senior Vice President and President of Medtronic Spinal, said that the new product demonstrates the company’s “long-term commitment to therapies for complex spine disorders for spinal tumour, trauma and deformity patients”.

Cancer patients can also benefit from the product. If the cancer has spread to the spine, the surgeon may replace the affected vertebrae with the T2 Altitude device.

More than 150,000 spinal fractures occur in North America every year, of which approximately 11,000 are spinal cord injuries.

Based in Memphis, Medtronic Spinal provides advanced treatment through the collaboration with surgeons and researchers to offer affordable, minimally-invasive products and medical technologies for neurological, orthopaedic and spinal conditions.

A new approach to spinal fusion surgery

by emma 4. November 2011 16:12

Medtech Product News

US-based Medtronic Spinal has launched a new type of spinal fusion surgery.

The MAST MIDLF procedure, announced to the North American Spine Society in Chicago, enables minimally invasive spinal fusion.

Described as a midline laminectomy, the procedure accesses the spine in the middle lower back, removing the need for the surgeon to work through a tubular retractor.

Over 250,000 people in the US undergo spinal fusions each year to treat degeneration of the lumbar spine.

“This surgical strategy enables a highly efficient, minimally invasive lumbar fusion, while allowing visualisation of familiar posterior landmarks,” said Dr. Richard Hynes, spine surgeon at The B.A.C.K. Center in Melbourne, Florida.

“A midline approach offers surgeons a number of benefits in addressing the challenges associated with decompression as well as sacral fixation in the lumbar or lower spine.”

The MAST MIDLFTM procedure can be used with Medtronic’s surgical navigation and imaging systems, improving the accuracy of device placement and reducing clinician exposure to radiation.

The new surgical procedure is the latest addition to Medtronic Spinal’s minimally invasive MAST portfolio of surgical treatments for degenerative and deformity-based spinal conditions.

Medtronic's spinal business, based in Tennessee, is a global leader in the treatment of spinal conditions.

RFID-based surgical sponge gains CE Mark

by emma 4. November 2011 10:14

Medtech Product News

The world’s first RFID-based systems for counting and detecting surgical sponges, avoiding their accidental retention after surgery, have gained CE Mark approval.

The SmartSponge and SmartWand-DTX products from US patient safety specialist ClearCount are also the first RFID-based surgical products to gain approval for marketing in the EU.

ClearCount is currently pursuing commercial partners for European distribution of the two systems.

The SmartSponge is a Radio Frequency Identification (RFID) system that verifies sponge counts and detects sponges retained within the patient, uniquely identifying each sponge used during an operation.

Retained surgical items are estimated to occur in one of every 1,500 open abdominal or chest procedures, leading to serious complications including further surgery, infections and even death.

In the UK, nearly 800 missing or retained surgical swabs or instruments have been recorded by hospitals in a single year.

“CE Mark approval of our SmartSponge System and SmartWand-DTX represents a significant achievement and major milestone for our company,” said David Palmer, CEO of ClearCount.

“We have established a perfect safety record over the past two years in the United States. Our hospital customers have never experienced a retained surgical sponge while using our technology.”

Based in Pittsburgh, ClearCount Medical Solutions is a medical device company specialising in patient safety solutions. The company received the 2009 Wall Street Journal Technology Innovation Award.

Vibrating gel could restore lost voices

by emma 3. November 2011 21:13

Vibrating Gel

A vibrating gel injected into the vocal tissues of the throat could restore vocal capacity to people whose voices have been damaged by surgery.

The new gel (pictured), developed by Harvard Medical School surgeon Steven Zeitels in partnership with MIT bioscientist Bob Langer, can vibrate up to 200 times per second, mimicking the action of human vocal cords.

Their research has been partly funded by singers Roger Daltrey (of The Who) and Steven Tyler (of Aerosmith), both of whom have suffered loss of singling ability following surgery, thought its main funding source is the Institute of Laryngology and Voice Restoration.

It has recently been reported that Dr Zeitels is helping to treat singer Adele, who has had to cancel her 2011 tour to undergo surgery to alleviate issues with her throat.

Injected directly into the vocal cords, the gel responds to breath and muscle tension by vibrating.

Zeitels is a professor of laryngeal surgery whose patients include singer Julie Andrews as well as Daltrey and Tyler. He was directed to Langer by a number of scientific experts.

Langer is famous for his work on anti-cancer drugs that starve tumours of their blood supply, including Roche’s Avastin, and on time-release drug delivery technologies for chemotherapy.

Creating artificial vocal cords requires a durable material that can bond with the existing tissue and respond correctly to muscle contractions and air movement. Langer has developed a polyethylene glycol gel tailored at the molecular level.

“With synthetic materials, the beauty is you can tailor them and build in the degradation rate or mechanical strength you need because you’re making them from scratch,” Langer commented.

Zeitels and Langer plan to test the gel in a cancer patient for the first time in 2012.

FDA approves first heart valve without open-heart surgery

by emma 3. November 2011 11:26

Medtech FDA news

The FDA has approved Sapien transcatheter heart valve (THV), an artificial aortic heart valve that can be placed without open-heart surgery.

Edward Lifescience’s device is the first artificial copy of an aortic heart valve to replace valves that have been damaged by senile aortic valve stenosis without open-heart surgery.

Dr Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health, said that the artificial valve “is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement”.

The approval was based on a study of 365 patients who were not eligible for open-heart surgery, half of which received the Sapien valve, the rest were given an alternative therapy that did not require open-heart surgery.

The study showed that patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant.

However, Sapien patients were more likely to survive one year after surgery, with 69% alive compared with 50% of those who received an alternative treatment.

Patients with severe aortic valve stenosis would usually have to undergo open-heart surgery to replace the valve, but some patients are unable to do so.

According to the FDA, more than half of all patients will die within two years of the onset of senile aortic stenosis.

Senile aortic valve stenosis is a progressive disease that can affect elderly patients. The condition incurs an accumulation of calcium deposits on the aortic valve, causing the valve to become narrower.

Devices shed light on sinus problems

by emma 1. November 2011 16:49

Relieva Luma Sentry Sinus Illumination System

Two new endoscopic devices launched in the UK promise to improve the success of surgery for treatment of chronic sinusitis.

The Cyclops Multi-Angle Endoscope and Relieva Luma Sentry Sinus Illumination System (pictured) from US company Acclarent give surgeons an enhanced field of view when navigating the sinus.

The sinuses are narrow and tortuous air spaces that can easily be blocked by minor inflammation. Sinusitis affects some 9 million people in the UK, with symptoms including headaches, facial pain, nasal blockage, toothache and fatigue.

The new Acclarent endoscopic devices enable the surgeon to see the natural opening of the sinuses directly, examining many angles with one scope.

These products add to the company’s Balloon Sinuplasty treatment platform, in which a tiny balloon is guided into the sinuses to help blockages.

Since its launch in 2005, more than 120,000 patients worldwide have been treated with Balloon Sinuplasty.

Based in California, Acclarent specialises in products for ENT surgery. The company is a business unit of Ethicon, a Johnson & Johnson company.

Eye robot helps surgical precision

by emma 31. October 2011 15:06

Medtech Innovation News

An eye-surgery robot designed to help surgeons with precision and ease during operations has been developed at Eindhoven University.

The system filters out hand tremors, which tend to occur more often with increased age.

Researcher Thijs Meenink said: “When ophthalmologists start operating they are usually already at an advanced stage in their careers. But at a later age it becomes increasingly difficult to perform these intricate procedures.”

The medical device allows the ophthalmologist to be in complete control, operating from the ‘master’ using two joysticks. Two robotic arms (the ‘slave’ developed by Meenink) then copy the master’s movements.

The surgeon’s movements are scaled down, so that each centimetre of joystick motion translates to only one millimetre of movement by the instrument “increasing the precision of the movements”, as Meenink commented.

Ophthalmologist Professor Marc de Smet, one of Meenink's PhD supervisors, said: “Robotic eye surgery is the next step in the evolution of microsurgery in ophthalmology, and will lead to the development of new and more precise procedures.”

Meenink has also designed an ‘instrument changer’, so that the robot can use different instruments during surgery. This reduces procedure time, as some eye operations can require as many as 40 instrument changes.

The first human operation using the new technology is expected within the next five years.

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