A video clip of a young American woman enabled by the first fully implantable hearing aid to hear her own voice clearly for the first time has become famous online.

Sarah Churman, aged 29, from Texas, was born profoundly deaf and has grown up using external auditory devices to provide partial hearing ability.

The surgical implantation of an Esteem device from Envoy Medical behind each ear resulted in her experiencing much clearer hearing.

Churman’s emotional reaction to her greatly improved hearing was filmed and uploaded to YouTube, where it became a massive hit despite user comments that showed ignorance about her condition.

The Esteem device is the first fully implantable hearing aid, with no microphone or speaker. Based on pacemaker technology, it is implanted under the skin behind the ear. Two leads extend into the middle ear from the device to sense the vibrations of the eardrum and auditory ossicles.

Churman commented that conventional hearing aids had never given her good discrimination of sounds or a sense of their distance: “With my hearing aids everything is jumbled, just white noise.”

Now, she added, voices were clear for the first time: “I could hear my two daughters’ words rather than having to read their lips.” In addition, she said, she was able to hear the sounds of rain, thunder and birdsong.

Each medical device and its implantation would cost nearly £20,000 in the UK, and is not available from the NHS.

Envoy Medical is based in Minnesota, USA.

VistaMed’s investment of €7.2 million in R&D and product expansion will create 79 jobs, nearly doubling its workforce.

The Irish company designs, develops and manufactures catheters and complementary medical devices, exporting to the UK, Europe, US, South America and India.

Paddy Mulholland, Managing Director of VistaMed, said that the company “has continued to develop its capabilities and today we offer a comprehensive design development and manufacturing of innovative catheter solutions”.

The company’s investment is supported by the government through Enterprise Ireland.

Currently, 93 people are employed by VistaMed at its facility in Leitrim.

The FDA has approved Crospon’s EF-800 external channel endoscopic accessory to deploy the company’s EndoFLIP catheters.

John O'Dea, CEO of Crospon, said that the medical device will enable the catheters to be used in “hard to access parts of the gastrointestinal tract”, for example, “measurement of stomas in the stomach created during bariatric surgery procedures”.

The company received FDA and CE Mark approval to market its EndoFLIP EF-900 gastric tube in July 2011, for use in bariatric surgery to provide support for sleeve gastrectomy, and to allow stomach decompression, gastric fluid drainage and removal.

Based in Ireland, Crospon develops minimally-invasive medical devices for monitoring, diagnosis and therapy in gastroenterology.

A medical device that helps to prevent wrong-route injections has won the Medical and Life Sciences Award at the first ever Made in Wales Awards in Cardiff.

The Hall Lock system (pictured) from Flexicare Medical, developed in partnership with clinicians at Cardiff University, is a series of connectors designed to reduce the risk of potentially lethal misconnections.

The system was developed in response to the increasing number of fatalities due to wrong-route injections of intravenous drugs and anaesthetics.

The cross-sectional shapes of the Hall Lock connectors are not compatible with each other or with a standard luer connector, presenting a mechanical obstacle to misconnection.

Hash Poormand, Flexicare’s Business Development Director, commented: “The Hall Lock System is a truly Welsh idea inspired by Cardiff University Hospital and designed by Flexicare in Wales.

“We are proud to be at the forefront of shaping the future of patient safety. This award recognises that innovation can be taken from concept to market with all the expertise required right in the heart of Wales.”

In a keynote speech at the Made in Wales Awards, Cheryl Gillan, Secretary of State for Wales, said: “The innovation recognised at the awards today is inspiring and I want to congratulate each and every winner: they are first-class examples of how Wales can contribute to new technologies and private sector growth.

“SMEs in Wales have a critical role to play in supporting the economy in Wales and I am clear that the UK Government is here to provide support to help companies succeed.”

Based in Mountain Ash, Flexicare Medical manufactures medical devices across a range of product areas including anaesthesia, critical care, breathing systems, suction, resuscitation, continence care and colostomy.

Healthcare giant Abbott plans to split into two companies: one in diversified medical products and the other in research-based pharmaceuticals.

The diversified medical products company will include medical devices, diagnostics, nutrition and generic drugs, and will retain the Abbott name.

The research-based drug company will cover Abbott’s existing portfolio of proprietary pharmaceuticals and biologics.

Abbott’s cardiac stents and other vascular devices have made the company a global leader in interventional cardiology.

Miles D. White, Chairman and CEO of Abbott, will remain Chairman and CEO of the diversified medical products company, which aims to be one of the largest and fastest-growing investment opportunities in this area.

The Abbott medical products company, whose current annual revenue is estimated at $22 billion, will continue to aim for double-digit growth and geographic expansion, particularly in emerging high-growth markets.

Its existing portfolio includes laboratory, point of care and molecular diagnostics and medical devices for cardiovascular, diabetes and vision care. It will develop an extensive and broad-based pipeline of medtech.

“Today’s news reflects another dynamic change in our company’s 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns,” said Miles D. White.

“Abbott will be one of the largest and fastest-growing global diversified medical products companies, with a compelling portfolio of durable growth businesses in medical technology, branded generic pharmaceuticals and nutritionals. We will continue to grow our product lines, market share and global presence, especially in emerging markets.”

The transaction will take the form of a tax-free distribution to Abbott shareholders of a new publicly traded stock for the new drug company.

Abbott currently employs nearly 90,000 people and sells a wide range of products in more than 130 countries.

Read more on this story on Pharmaceutical Field.

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.”

Precision Engineered Products (PEP) has acquired Boston Endo-Surgical Technologies (BE-ST), a specialist in the development of spinal and orthopaedic surgical instruments.

BE-ST provides a firm pipeline of technologies to strengthen PEP’s spinal surgery portfolio.

Alan Huffenus, CEO of PEP, said that the acquisition of BE-ST will continue the company’s “strategy of expanding our offering of highest technology medical devices that extend people’s lifespan and improve outcomes of surgical procedures”.

Massachusetts-based PEP is a manufacturer of surgical instruments including surgical stapling devices, endoscopic and laparoscopic devices and drug delivery systems.

European medtech industry association Eucomed will launch a conference pre-vetting system in early 2012 to assess all third-party educational conferences and congresses sponsored by its members.

The new system is the first of its kind in the healthcare industry, because its assessments will be binding.

The independent Eucomed Compliance Panel will assess educational events for compliance with the association’s Code of Ethical Business Practice in relation to such factors as scientific content, location and venue.

Each outcome will be made publicly available via a dedicated website, and relevant stakeholders will be notified.

The Eucomed Code allows member companies to sponsor third-party educational events such as medical congresses, seminars and training courses, subject to restrictions. Until now, members had to establish their compliance independently. The new system will apply a uniform compliance determination process to all Eucomed members.

“The conference pre-vetting system is a unique initiative in the healthcare sector,” said John McLoughlin, Chairman of the Compliance Panel. “It will be supervised solely by our Panel, which is a completely independent body. Eucomed members are required to follow the assessments.

“If a conference receives a negative assessment, Eucomed members may not sponsor either the conference or individual healthcare professionals who wish to attend the conference.”

John Wilkinson, Eucomed’s Chief Executive, added that the new system “is not only necessary for our members in their day-to-day activities but is also key to increasing the consistency and transparency of industry behaviour.”

Eucomed intends to give key stakeholders an opportunity to comment on the assessment criteria.

The pre-vetting system will begin as a pilot and be reviewed 6–12 months after its launch. It will be the sole responsibility of the Compliance Panel.

Eucomed represents 22,500 designers, manufacturers and suppliers of medical technologies in Europe.

CorMatrix Cardiovascular, developer of extracellular matrix (ECM) biomaterial devices, has received FDA approval for its CorMatrix ECM device.

The indication for use in the US relates to the vascular reconstruction and repair of the carotid artery, including patch closure following endarterectomy and suture line buttressing.

David Camp, Chairman & CEO of CorMatrix, said: “We believe the unique properties of our CorMatrix material provide a new and vital alternative to current approaches in carotid artery repair.”

The device utilises CorMatrix’s ECM technology to provide a natural bio-scaffold to enable adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells, ending in the repopulation and repair of damaged tissue.

The company currently has US and European approval for its ECM technology as an implant for pericardial closure and for use in cardiac tissue repair.

Based in Atlanta, Georgia, CorMatrix Cardiovascular both develops and delivers cardiovascular devices that harness the body’s ability to repair damaged tissue.

The first range of antimicrobial electric switches has been launched through a collaboration between two UK companies.

Switch specialist Arcolectric has launched its new range (pictured) in partnership with BioCote, a leading supplier of antimicrobial technology.

BioCote’s silver ion coatings have been shown to reduce levels of bacteria, mould and fungi on surfaces by up to 99.99%.

Arcolectric’s ranges of standard and miniature rocker switches, push button switches, double pole splash resistant switches and splash/dust covers will be manufactured with BioCote’s silver ion coatings.

The new coatings mean the switches, already used widely by healthcare equipment OEMs, will have antimicrobial protection for their lifespan.

Arcolectric has undergone a rigorous R&D and testing process for the new antimicrobial component range, while the BioCote brand is independently tested (in hospitals and other locations) and guarantees over a 95% reduction in bacteria.

“Our partnership with BioCote ensures the surfaces of Arcolectric switches will help prevent the spread of microbes including viruses, mould and bacteria,” said Stuart Hutchings, Marketing Manager at Arcolectric. “We anticipate a strong reaction from our customers to these significant enhancements to our best selling ranges.”

Based in Surrey, Arcolectric (part of Elektron Technology) is a leading global manufacturer of specialist appliance switches.

Wolverhampton-based BioCote incorporates antimicrobial technology into products at the time of manufacture, contributing to infection prevention in a range of care and other environments.