A Medical Device Daily
Atrium Medical (Hudson, New Hampshire) said it has begun enrollment of the first patients for CONFIRM 1, its first-in-man (FIM) drug-eluting coronary stent clinical trial.
The European FIM clinical trial is evaluating the company's Cinatra voclosporin-coated stent system. The trial will compare the Cinatra DES system to Atrium's Cinatra bare-metal coronary stent platform.
This first study of voclosporin on an implantable medical device will enroll 100 patients at seven hospitals in Belgium. Glenn Van Langenhove, MD, PhD, of Middelheim Hospital (Antwerp), is principal investigator.
The primary endpoint of the trial is to evaluate the safety and performance of the Cinatra voclosporin-coated coronary stent system and the bare-metal system in patients with de novo coronary artery disease. Patient outcomes will be assessed by measuring late lumen loss, with in-stent and in-segment measurements at six months following implantation.
Atrium said it is "excited to be able to study the new Cinatra coronary stent platform with voclosporin, a promising new drug, and [our] all-natural O3FA coating technology that merges the desirable safety benefits of a bare-metal stent with the clinical advantages of a bio-absorbable Omega 3 fatty acid coating."
The company said use of the patented Omega 3 coating platform, together with its novel drug compound, "has created a new class of patient treatment options who require a drug-eluting coronary stent. Interventional cardiologists and patients alike have been waiting for a new technology that delivers the effectiveness of a drug-eluting stent with a safer, more natural, non-polymer coating platform, resulting in a well-healed implant shortly after insertion."
The Cinatra is an advanced cobalt chromium balloon expandable stent, mounted on a low-profile, rapid-exchange catheter. Both stent and balloon are coated with the Omega 3 coating technology.
Voclosporin, a next-generation calcineurin inhibitor, is a product of Isotechnika (Edmonton, Alberta) and was licensed exclusively to Atrium Medical in 2005 for use with implantable devices.
Xtent cites progress toward CE mark
In other DES news, Xtent (Menlo Park, California) issued an update regarding its application to a designated European Notified Body for CE-mark approval of the Custom NX DES System.
Xtent said its Notified Body confirmed that recently-presented six-month follow up results from the CUSTOM III study will be incorporated by the European Drug Approvals Agency, which reviews the drug formulation submission of the company's CE-mark application, into its current review cycle.
The CE-mark application, which included two components — the Xtent design dossier and the drug formulation submission — was filed last December.
"Given the positive results of CUSTOM III, we are encouraged that the Drug Agency, which has already approved Biolimus A9 and PLA combinations on two other DES platforms, has accepted the additional data for review," said President/CEO Gregory Casciaro. "We believe this strengthens an already robust submission for our Custom NX System."
The company said it anticipates a response from its European Notified Body regarding the CE-mark application this summer.
BioGlue approved for brow lift surgery
CryoLife (Kennesaw, Georgia) and BioForm Medical (San Mateo, California) reported that they have received a CE mark for the use of CryoLife's BioGlue Surgical Adhesive for periosteal fixation following endoscopic browplasty or brow lift, a reconstructive plastic surgery procedure.
BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body's clotting mechanism, within 20 to 30 seconds, and reaches its maximum bonding strength in two to three minutes.
It will be distributed by BioForm, for use in approved cosmetic and reconstructive plastic surgery in the EU, under the brand name BioGlue Aesthetic Medical Adhesive.
CryoLife is the exclusive supplier of BioGlue to BioForm for all cosmetic and plastic surgery applications, and BioForm is responsible for all clinical trials and regulatory filings, and for sales and marketing of BioGlue in these applications in 12 EU countries.
"BioGlue has many potential applications in aesthetic surgery, and we are particularly excited about its promise in brow lift surgery. This is an important step in our overall development strategy to evaluate the use of BioGlue as a quick and easy-to-use fixation method in plastic surgery," said Steven Basta, CEO of BioForm. "The CE mark will enable us to accelerate development and evaluation of BioGlue applications with European physicians."
He added, "We will not commercially launch BioGlue in the EU until further clinical development is completed, but the product will be available in Europe on a limited basis to early users who will help us in the evaluation and development program. This program will complement the development program in the U.S., where we are advancing toward a planned U.S. pivotal study of BioGlue for use in browplasties."
"BioGlue has proven to be a safe and effective product and it has been used in over 400,000 procedures worldwide," said CryoLife President/CEO Steven Anderson. "
1st implantation of True Total implant
Disc Motion Technologies (Boca Raton, Florida) reported the completion of the first surgical procedure to implant its True Total Spinal Motion Segment System (TSMS), which it said is the first total joint replacement system for the lumbar spine featuring an artificial lumbar disc and posterior dynamic stabilization device (PDS).
The procedure was performed in May at Ankara Numune Education and Training Hospital (Ankara, Turkey) by Dr. Erkan Kaptanoglu of the department of neurosurgery.
He said, "The familiar posterior surgical approach used to implant the True TSMS avoids the potential dangers of vascular complications as seen with devices using an anterior approach, thus leading to better patient outcomes."
Tai Friesem, MD, who with Manoj Krishna of Stockton-on-Tees, UK, developed the devices, also attended the surgery and provided additional training. He said, "The True TSMS can be used in a wider number of patients than the anterior lumbar devices. The unique system deals with all three pain generators — the disc, nerve and facet joint — [and] increases range of motion in patients who suffer from the debilitating effects of DDD."