Sonitus Medical (San Mateo, California), a company that makes a non-surgical and removable hearing prosthetic to transmit sound via the teeth, said it has received CE mark certification for its SoundBite hearing system.
The company said it has received its EC certificate, which indicates full quality assurance system approval. This is the company's first European regulatory certification.
“Receiving the CE mark for our SoundBite hearing system is a significant milestone toward the global commercialization of our non-surgical bone-conduction hearing device,“ said Amir Abolfathi, CEO of Sonitus. “We intend to pursue the process of reimbursement registration in the key EU countries in the coming months and then gain initial European clinical experience with the product in partnership with a limited number of Otologists, ENTs, and Acousticians in the EU.“
SoundBite is designed to help people who are essentially deaf in one ear regain their spatial hearing ability. It uses a principle called bone conduction to deliver clear, high quality sound to the inner ear. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove ITM (in-the-mouth) hearing device – which is custom made to fit around either the upper left or right back teeth – and a small microphone unit worn behind the ear. No modifications to the teeth are required. This system currently has FDA 510(k) clearance and CE mark certification to treat single sided deafness. Intended future indications include conductive and mixed hearing loss.
Boston Scientific wins CE mark for Omega BMS
Boston Scientific (Natick, Massachusetts) reported that it has received the CE mark for its Omega platinum chromium bare-metal coronary stent system, the company's third-generation coronary stenting technology. The Omega stent system incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and is intended to provide interventional cardiologists a bare-metal stent with improved acute performance in treating patients with coronary artery disease. The company will begin marketing the system immediately in the European Union and other CE mark countries.
“In my experience, the platinum chromium alloy and stent design used in the Omega stent offer excellent deliverability, visibility and conformability without sacrificing radial strength or resistance to stent recoil,“ said Antonio Colombo, MD, director of the Cardiac Catheterization Laboratory at Columbus Hospital and San Raffaele Hospital (both Milan, Italy).
The Omega system is part of the company's PtCr stent series, which includes the Taxus Element paclitaxel-eluting stent and Promus Element everolimus-eluting stent systems. All three stents feature the PtCr alloy and a stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil. The higher density alloy provides superior visibility while permitting thinner struts compared to prior-generation stents, the company said. The enhanced delivery system features a dual-layer balloon and is engineered to improve access to challenging lesions.
The Omega stent is offered in 48 different sizes ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm.
Supersonic Imagine presents study results
SuperSonic Imagine (Aix-En-Provence, France) presented the validation of a worldwide multi-center study, based on European recruitment, confirming the benefit of ShearWave Elastography when added to ultrasound for improved lesion classification.
Launched by SuperSonic in June 2008, the global, multi-center study was conducted across 16 American and European sites involving 1,800 patients with breast lesions.
The first major result of this study demonstrated that ShearWave Elastography is reproducible both quantitatively and qualitatively. This reproducible technology provides strong assurance of precise tissue evaluation during diagnosis and is expected to be also useful in follow-up, the company said.
The second important outcome is a statistical model based on 939 lesions, which showed that ShearWave Elastography increases the performance of ultrasound breast cancer diagnosis. The addition of ShearWave Elastography features, such as maximum elasticity (stiffness) or heterogeneity (uniformity) of a lesion, to B-mode ultrasound, would permit an improvement in the BI-RADS classification accuracy, (standardization tool for breast lesion classification from the American College of Radiology) improving breast diagnosis.
In Europe, 1,223 lesions have been examined, including 425 cancers (34.8%). The European study was conducted across four sites in France (332 lesions), four sites in Germany (585 lesions), one site in Italy (104 lesions) and one site in the UK (202 lesions).
Medtronic launches Achieve catheter in Europe
Medtronic (Minneapolis) reported the European launch of the Achieve mapping catheter, an intra-cardiac electrophysiology recording catheter that can be used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation (PAF). The innovative catheter technology, which has received the CE mark, is designed to be used with the Medtronic Arctic Front Cardiac CryoAblation Catheter System, offering a more straightforward approach to the minimally invasive procedure.
The Achieve Mapping Catheter has a distal mapping section with a circular loop which is available in two loop diameters (15 mm and 20 mm). It is deployed through the Arctic Front guidewire lumen, allowing for a single transseptal puncture. The catheter features eight evenly spaced electrodes on a loop, enabling physicians to map electrical conduction between the left atrium and pulmonary veins. Additionally, the catheter allows for assessment of pulmonary vein potentials both before and after cryoablation and also helps physicians assess time-to-effect during cryoablation.
“The Achieve Mapping Catheter offers a significant enhancement to the Arctic Front system – presenting physicians with a simplified approach to pulmonary vein isolation,“ said Reggie Groves, VP and general manager of Medtronic's AF Solutions division. “We are committed to providing physicians with the most advanced medical technology to treat heart rhythm diseases and improve patient quality of life.“
Cardica receives CE mark for Microcutter
Cardica (Redwood City, California) reported that an initial Microcutter surgical cutting and stapling device developed by Cardica has received CE mark certification.
As an integral part of the multi-step CE marking process, Cardica has obtained a Full Quality Assurance certification for its Microcutter design and manufacturing processes. With this certification, after successful completion of development, Cardica can apply the CE mark to the first Microcutter product that Cardica expects to commercialize, the Microcutter XPRESS 30, and will be able to apply the CE mark to future devices within the Microcutter product line that comply with the certified design and manufacturing processes in the same manner.
“Receiving the CE mark for an initial Microcutter device is a significant milestone in our progress towards the commercialization of Cardica's innovative and proprietary staple-on-a-strip technology,“ said Bernard Hausen, MD, PhD, president/CEO of Cardica. “Moving forward, we expect to successfully complete development of the Microcutter XPRESS 30 and begin using it in selected European surgical centers to gain initial experience with the product. Integrating feedback from our initial experience in Europe, we intend to conduct a limited market release of our XPRESS 30 product to nearly 20 to 30 leading surgeons in the U.S. in mid-2011, subject to FDA clearance under a 510(k) process.“
Ventus gets CE mark for Provent sleep apnea device
Ventus Medical (Belmont, California) reported receiving CE mark for its Provent sleep apnea therapy. Provent is a disposable, prescription device indicated for the treatment of obstructive sleep apnea (OSA). The device works through the company's MicroValve technology that uses the patient's own breathing to create expiratory positive airway pressure to keep the airway open during sleep.
“We are pleased to accomplish this important regulatory milestone. Receiving CE mark for Provent Therapy will facilitate our international commercialization strategy and allow us to launch this product in selected countries over the next several months,“ said Peter Wyles, president/CEO of Ventus Medical. “We intend to introduce Provent Therapy internationally in a systematic way through established distributors, focusing on countries with a high prevalence of obstructive sleep apnea. There is a clear need for therapeutic options other than CPAP and Provent Therapy represents an attractive new alternative.“
OSA is the most common type of sleep-disordered breathing, Ventus said. It is estimated that one in 20 adults worldwide suffer from sleep apnea, with population-based studies suggesting that certain countries have a higher prevalence of OSA. In those with OSA, the airway collapses during sleep when the muscles, that hold the airway open, relax.
Provent is FDA cleared.
Life Spine gets CE mark for slew of products
Life Spine (Hoffman Estates, Illinois) said it has received CE mark approval for its spinal systems; pedical screw systems (Conquest, Pilot, ARX, and Avatar), cervical plate systems (NEO, NEO-SL, Kinetic, Kinetic-SL), and interbody spacer systems (Plateau, Plateau-A), as well as its Octave posterior fusion system.
The CE mark approval comes on the heels of the company's receipt of ISO 13485 certification achieved through demonstrating a robust quality assurance system in accordance with international standards, the company noted
“The CE mark is an important milestone not only for continuing our sales efforts in other foreign markets but also to accelerate our product development efforts,“ said Michael Butler, president/CEO of Life Spine.
Kelcourt opens new plant in Ireland
Kelcourt Plastics (San Clemente, California), a component supplier to the medical device industry, said it is establishing a new medical tubing manufacturing operation in Tullamore, Ireland with the support of IDA Ireland.
Kelcourt Ireland will create 55 new jobs over five years and is making a significant capital investment in its building at the IDA Business and Technology Park in Tullamore, the company said.
Kelcourt's medical tubing capabilities and PPC's medical packaging portfolio aims to create perfect synergy into a range of key medical device applications that will be locally sourced in Ireland. The company also plans to target the European market with its range of medical tubing and packaging solutions.
The Irish operation will also establish a product development function to work closely with client R&D teams on new product concepts. The specialized tubing that will be manufactured at the plant will be used in hundreds of medical areas, including anesthesia, urology, cardiology, surgery, IV systems and emergency medicine.
“We searched for the right location to establish an operation to meet the demand for our medical and speciality tubing capability, as well as our packaging capabilities in Ireland,“ said Patrick Mickle, president of Kelcourt.
CRT market in Europe to reach over €1 billion
According to a new report by iData Research (Vancouver) the European cardiac rhythm management (CRM), electrophysiology and ablation market was valued at over €2.8 billion in 2010. Medtronic (Minneapolis), St. Jude (St. Paul, Minnesota) and Biotronik (Berlin) have emerged as leaders, particularly in the telehealth monitoring for cardiac implantable electric device (CIEDs) segment, which is expected to grow at double-digit rates by 2017.
CRT devices were the fastest growing in 2010 and sales will reach over €1 billion due to recent technological advances in wireless connectivity and miniaturization. By 2017, the total European CRM, electrophysiology and ablation markets are expected to reach over €4.4 billion, according to the report.
The report says that in 2010, the UK exhibited the fastest growth per-capita in CRM device implantation due to NHS targets to increase the use of implantable cardioverter defibrillators, and CRT devices in order to reach a per-capita level similar to the European average. In addition, pilot programs for the use of remote monitoring have stimulated growth of telehealth monitoring for CIEDs.
Argus II wins market approval in Europe
An implant designed to restore a degree of sight to people with advanced retinal degenerative diseases has been approved for sale in Europe.
The Argus II retinal prosthesis system was developed by Second Sight Medical Products (Sylmar, California).
After a clinical trial involving more than 30 blind patients, and a review of the product's safety and performance by an independent expert body, the device is said to be the first approved treatment ever available for sightless people, according to the company.
“After years of research, we are . . . able to offer a viable long-term solution for people suffering from advanced retinal degenerative diseases such as retinitis pigmentosa [RP],“ said Robert Greenberg, president/CEO and managing director of Second Sight. “The CE mark approval . . . represents a huge step forward for the field and for these patients who have, until now, had no proven treatment alternatives.“
Argus II is Second Sight's second-generation implantable device intended to treat profoundly blind people suffering from degenerative diseases such as RP.
Second Sight said in a statement that the system converts video images captured from a camera – housed in the patient's glasses – into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the retina.
The company plans to make the Argus II available later this year.
dbMotion and Matrix partner in UK venture
dbMotion (London), a provider of connected healthcare solutions, and Matrix Knowledge Group (London), a provider of information management services, reported a partnership to jointly market and deploy solutions throughout the UK.
According to the companies, the combination of Matrix Knowledge Group and the dbMotion Solution allows clients to leverage robust change management methodologies with a proven product suite that integrates fully with existing systems and can be rolled out at a gradual pace without the need for a complete overhaul of IT infrastructure. The dbMotion virtual patient record approach creates a single point of truth for health data within a trust or a community. It then becomes the cornerstone for many new applications, including a web-based patient record viewer, collaboration tools, data analytics, population management and public health. Results achieved by existing dbMotion customers include reductions in hospital admissions and length of stay, decreased volume of diagnostic and laboratory tests, improved quality of diagnostics, and increased efficiency in clinical workflows, the companies said.