A Medical Device Daily
Endovascular technology firm ev3 (Plymouth, Minnesota) said it has received CE-mark approval for its Axium Detachable Coil System for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
It also is intended for use in the European Union for the treatment of peripheral vascular abnormalities.
The company said Axium "incorporates several innovative technologies designed to meet the performance 'wish list' of a diverse group of leading neurosurgeons and interventional neuroradiologists."
It said the design, development and testing of the new system "was a highly collaborative process led by a dedicated team of ev3 engineers and leading coiling experts from around the world." The latter included Gary Duckwiler, MD, professor of interventional neuroradiology at the University of California, Los Angeles, and Saruhan Cekirge, MD, and Isil Saatci, MD, both professors of neuroradiology/interventional neuroradiology at the Hacettepe University School of Medicine (Ankara, Turkey).
Among the "wish list" requirements identified by the team:
• A high degree of coil conformability, which facilitates the physician's goal of more easily and completely filling and packing the aneurysm, regardless of its shape or size.
• Coil softness combined with stretch resistance, which allows the coil to be positioned or re-positioned within the aneurysm without adding to the risk of bleeding or hemorrhagic stroke.
• Ease of coil placement through the microcatheter, providing the physician with enhanced control and deliverability.
• Rapid, safe and simple detachment of the coil through a proprietary, micro-machined and first-of-its-kind Instantaneous Detacher device that offers instantaneous coil detachment without the use of wires or syringes. According to ev3, "this unique feature facilitates precise and rapid coil deployment while minimizing procedure time, which may be especially important in a ruptured aneurysm or when blood flow to the brain has been restricted."
Left untreated, cerebral aneurysms can rupture and cause stroke or death. The minimally invasive treatment of cerebral aneurysms uses detachable coils such as the Axium to embolize the aneurysm. The coiling procedure involves the delivery of platinum coils to the aneurysm via a small microcatheter. The coils are threaded through the catheter into the aneurysm until the ballooned area is completely filled while still maintaining normal blood flow through the rest of the vessel.
Duckwiler said, "While coiling technology has improved over the last few years, I believe that the advancements made possible with Axium will offer significant benefits to physicians, and therefore, their patients. The new coil has met many of the performance requirements we laid out in development, including better conformability and the precision and ease of coil placement. And the new detachment system is an added bonus for instantaneous coil release, which not only speeds the procedure but eliminates the need for wires or syringes."
Dental 'bandage' approved in Europe
HemCon Medical Technologies (Portland, Oregon) said it has received the CE mark for what it termed its "unique" dental dressing. The company said that since the HemCon Dental Dressing's U.S. launch last year, international demand has been strong.
With receipt of this certification, HemCon will be positioned to begin distributing into countries requiring the CE mark, including Great Britain, Germany and the rest of the EU.
The HemCon Dental Dressing is designed to be used by oral surgeons and dentists following tooth extractions and other oral procedures. The dressing also has been used to treat oral trauma. The company said the dressing uses the same materials and technology as its other dressings, which are used by the military and emergency medicine professionals to control severe bleeding.
"The HemCon Dental Dressing represents a significant advance in the standard of treating oral wounds," said John Morgan, HemCon president and CEO. "The CE mark will now allow us to increase our market presence to other key countries."
The dressing measures 10 mm x 12 mm and, when placed in an extraction socket, adheres to the surrounding tissue, protecting it and providing pain relief. The bandage is designed to dissolve within seven days.
"The HemCon Dental Dressing was very impressive during our testing," said Dr. Jay Malmquist, lead clinical investigator and former president of the American Association of Oral and Maxillofacial Surgeons. "The dressing provided protection of the wound site and sealed the wound in well under a minute in most cases, compared to about 15 minutes with gauze. The HemCon Dental Dressing also performed very well on patients who were on blood thinners."
The HemCon bandage was developed in collaboration with the Oregon Medical Laser Center and Providence St. Vincent's Hospital (both Portland).
Pearl laser from Cutera gets CE mark
Cutera (Brisbane, California), a global provider of laser and other light-based aesthetic systems, reported receiving CE-mark approval for its new laser, Pearl, with proprietary YSGG technology.
The Pearl system received FDA clearance in March and represents, according to Cutera, the first application of the 2790 nm wavelength for cosmetic dermatology.
President and CEO Kevin Connors said, "We will immediately begin shipping Pearl into the EU community and other countries that recognize the CE mark."
Cutera will market Pearl, a minimally invasive laser, in Europe to improve the appearance of wrinkles, uneven texture, age spots and sun damage with only one or two treatments and minimal downtime. The company said clinical data supports that Pearl's controlled thermal effect creates residual heat in the upper dermis, stimulating new collagen production.
Cutera said it believes Pearl will become "a leading skin-rejuvenation procedure because of its patient-friendly approach and excellent clinical results."
Pearl is available on Cutera's multi-application Xeo platform, as an upgrade to all existing customers or as a stand-alone unit.