A Medical Device Daily
Medinol (Tel Aviv, Israel) reported the availability of its bare-metal Presillion cobalt chromium (CoCr) coronary stent in Europe. The distributor of the stent, Cordis (Warren, New Jersey), said the system "provides flexibility that delivers the stent through the arteries, and conformability and scaffolding that adapts to the vessel when deployed."
"The Presillion stent had a very smooth delivery and passed the calcified area proximal to the lesion quickly," said Eberhard Grube, MD, chief of cardiology at Heart Center Siegburg (Siegburg, Germany), who recently performed a case with the stent. "The final angiogram showed the excellent conformability and scaffolding of the Presillion stent to the vessel walls."
The Presillion stent consists of alternating rings of narrow and wide struts that Cordis said are optimized to give "excellent flexibility with the narrow struts while maintaining optimal radial strength with the wide struts."
It said the "unique stent design includes an adaptive closed cell architecture that is capable of differential lengthening. This enables the stent to be flexible in the unexpanded configuration, and support the vessel while conforming to its curvature in the expanded configuration."
The Presillion stent is available in lengths that range from 8 mm to 33 mm and in a variety of diameter sizes from 2.5 mm to 4.0 mm.
Kobi Richter, PhD, chairman/chief technology officer of Medinol, said, "Cobalt chromium enables us to reduce the strut thickness and overall cell size by up to 25% compared to stainless steel, while retaining superior scaffolding through the unique flexible closed cell design."
He said the material "also maintains a much higher fatigue resistance and radiopacity than the common stainless-steel stents."
Medinol received the CE mark for the stent in March. Cordis, a Johnson & Johnson (New Brunswick, New Jersey) company, is the exclusive global distributor of the Presillion.
CE mark for AGA's Amplatzer Plug
AGA Medical (Plymouth, Minnesota) reported receiving CE-mark approval to market its Amplatzer Vascular Plug III (AVP III), and said it has launched the device in the European Union.
The company said the AVP III further expands its line of occlusion devices designed to embolize, or close, blood vessels and blood vessel malformations in the peripheral vasculature.
"We believe the new AVP III is another strong addition to the AGA vascular plug family," said president/CEO Franck Gougeon. "Our goal is to provide physicians with a toolbox of embolization devices that can treat vessels of different types and length and with different flow characteristics."
The AVP III is a self-expanding nitinol mesh device designed to be introduced in a minimally invasive fashion through a catheter. The device comes pre-attached to a delivery cable by a small screw; the delivery cable enables the physician to precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released.
The company said the nitinol mesh retention discs "ensure the secure positioning of the device, even in high-flow vessels."
Gougeon said, "Our pre-clinical testing suggests that the AVP III will have the fastest occlusion times within our vascular plug family."
The AVP III is under review by FDA for clearance to market in the U.S.
AGA is a developer of interventional devices to treat structural heart defects. Its line of devices is focused on treatment of the most common congenital "holes in the heart," such as atrial septal and patent foramen ovale defects.
The company said it is expanding into new areas such as the minimally invasive repair of vascular abnormalities.
AGA's products are marketed in 101 countries, with more than 278,000 devices shipped to date.
UK distributor chosen by Zila
Zila (Phoenix) said it has selected Panadent (Orpington, UK) to be the exclusive distributor of ViziLite Plus with TBlue, Zila's oral cancer screening product, in the UK and Ireland.
Terms of the agreement were not disclosed.
Panadent launched ViziLite Plus at the British Dental Conference & Exhibition, the British Dental Association's annual conference, in Manchester, UK, early this month.
David Bethune, chairman/CEO of Zila, said, "Panadent's specialty in selling dental products to dentists and hygienists through education, technical expertise and service will make them an effective marketer of ViziLite Plus. The UK market represents a significant opportunity for Zila and establishes a solid foothold for expanding throughout the rest of Europe."
Peter Gowers, managing director of Panadent, said, "ViziLite Plus is a much-needed oral cancer screening product for patients in the UK. Given that 25% of oral cancers occur in people who do not smoke and have no other behavioral risk factors, it is imperative that every adult, particularly those at high risk for oral cancer, be screened at least once a year."
ViziLite Plus uses a chemiluminescent light source and a pharmaceutical-grade vital tissue dye, TBlue, to help dentists and dental technicians identify and evaluate abnormalities in the mouth that could harbor pathologic changes.