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.

New sleep apnoea treatment gains CE Mark

by emma 28. October 2011 14:41

Medtech Innovation News

A neurostimulation device that offers sufferers from obstructive sleep apnoea (OSA) an alternative to continuous positive airway pressure (CPAP) therapy has gained CE Mark approval.

The Hypoglossal Nerve Stimulation (HGNS) system from US company Apnex Medical has been approved for sale in Europe based on the results of clinical studies in the US and Australia that showed the device to reduce the symptoms of OSA.

OSA – an inability to breathe during sleep – is estimated to affect 100 million people worldwide. It causes excessive daytime fatigue and increases the risk of stroke, heart disease and death.

CPAP therapy is the current standard for OSA, but many patients cannot tolerate it or comply poorly with it. The HGNS system offers a radically different approach: an implantable therapy that activates the muscles in the upper airway.

Implanted in the shoulder, the HGNS system measures the patient’s breathing during sleep and delivers mild electrical pulses to the hypoglossal nerve (which controls the tongue) to keep the airway open.

The system can be programmed to operate only when the patient is asleep, or be turned on and off with a hand-held switch.

The Apnex Clinical Study, a randomised clinical trial, is ongoing in the USA, Europe and Australia. It is designed to test the safety and effectiveness of the HGNS therapy in patients with OSA in whom CPAP therapy has not been effective.

“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnoea and is a key milestone for our company,” said Chas McKhann, President and CEO of Apnex Medical. “We are excited to bring this innovative new therapy to Europe.”

Based in Minnesota, USA, Apnex Medical specialises in innovative therapies for sleep-disordered breathing.

FDA approves stent for gastric diseases

by emma 19. October 2011 12:44

Evolution Duodenal Controlled-Release Stent

The FDA has approved Cook Medical’s Evolution Duodenal Controlled-Release Stent for patients with malignant gastric outlet obstruction (GOO).

The stent is the only duodenal stent delivery system that allows for controlled release and recapturability, expanding palliative care options for patients experiencing issues with malignant GOO and extending the company’s product portfolio for the treatment of gastric diseases.

Barry Slowey, Global Business Unit Leader for Cook Medical’s Endoscopy division, said that the product “provides physicians with highly accurate stent placement, reducing the risk of migration, perforation and minimizing the need for repeat procedures”.

The Evolution’s design using 18 crowns at both ends of the stent allows the product to adapt to the anatomy’s shape. The proximal and distal flanges are designed to reduce the risk of stent migration, while the product’s Flexor catheter provides trackability and manoeuverability for deployment in the hard-to-reach duodenum.

Dr Willis Parsons, Medical Director of the Northwest Community Hospital Gastroenterology Center, said: “The stent platform is designed for optimal trackability and manoeuverability in difficult angulations, providing superior stability at crucial points during delivery.”

The stent was used in a multicentre study of 23 European patients, of which 21 patients had significant improvement of symptoms.

Mr Slowey added: “This stent has been used to treat thousands of patients around the globe, potentially improving quality of life for these patients, and hopefully minimizing the painful symptoms associated with this disease.”

Meningitis test for quicker diagnosis

by emma 7. October 2011 16:50

MB product news

Belfast Health and Social Care Trust has licensed a new rapid meningitis diagnostic test for worldwide exclusive marketing rights.

The new test, developed by scientists at the Royal Victoria Hospital and commercialised by Irish start-up company HiberGene Diagnostics, uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP), that can to provide reliable diagnosis within an hour.

Meningitis is a difficult disease to diagnose as symptoms are typically flu-like. Standard laboratory tests take at least 24 hours to process, and there is a need for rapid and accurate results to allow earlier confirmation to enable earlier treatment.

Brendan Farrell, CEO of HiberGene Diagnostics said: “We are particularly pleased to have secured exclusive rights to the meningitis test from the Belfast Trust. Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7% which is excellent.”

Consultant Paediatrician Professor Mike Shields, who led the research, said: “Meningitis presents a clinical challenge for the emergency department doctor because the patient's symptoms can be non-specific.

“No doctor wants to send a seriously sick child home, which is why this new diagnostic test holds such promise. When this test is available it will have the potential to save many lives.”

HiberGene Diagnostics Ltd is a start-up client company of NovaUCD, the Innovation and Technology Transfer Centre at the University College Dublin.

The company plans to market the test in the first half of 2012 and is in discussions with potential distribution partners in the US and Europe.

Lilly’s erectile dysfunction drug approved in US

by emma 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.

Computer can detect pain, claims study

by emma 16. September 2011 13:28

MB Innovation news

A new computer learning software can detect when people are in pain, claims a new US study.

A team at Stanford University in California have claimed that data gathered from brain scans can teach the computer through patterns of brain activity to determine whether or not someone was experiencing pain with 80% accuracy.

Doctors currently rely on patients communicating their symptoms, which can be unreliable, or in some cases impossible, regarding the very young, very old, or those who are unconscious.

Dr Sean Mackey, head of the study, said: “People have been looking for a pain detector for a very long time”.

For the study, eight volunteers underwent brain scans whilst touching hot objects, and hotter objects that were painful to touch.

The computer, which used linear support vector machinery – algorithms invented in 1995 – used the data to recognise the differences in patterns of brain activity.

“We're hopeful we can eventually use this technology for better detection and better treatment of chronic pain.”

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