A Medical Device Daily
Biotronik (Berlin) reported completing enrollment in the ProLimus I first-in-man trial with its ProGenic pimecrolimus-eluting coronary stent system.
The ProLimus I trial is a prospective, non-randomized, multi-center clinical trial with 61 patients enrolled at five sites in Belgium and Germany. Safety and clinical performance of the ProGenic pimecrolimus-eluting stent are evaluated in patients with single de novo coronary artery lesions.
The ProGenic stent is comprised of four elements: The PRO-Kinetic Cobalt Chromium Stent System; the PROBIO silicon carbide passive stent coating as a protective layer that reduces metal ion release and promotes endothelialization; a bioresorbable Poly-L-Lactic Acid polymer drug carrier and what the company termed "the next generation in vascular drug technologies, pimecrolimus."
Following implantation of the ProGenic stent, drug and polymer is completely absorbed, leaving PROBIO as a long-term safety feature.
Biotronik said the trial is "closer to everyday clinical practice than most first-in-man trials, allowing investigators to include patients with two-vessel disease."
Clinical follow-up is conducted at 30 days, six months, 12 months and annually up to three years. At the six-month follow-up, all patients will undergo coronary angiography and intravascular ultrasound (IVUS) evaluation.
The primary endpoint of ProLimus I is a composite of major adverse cardiac events (MACE) at six-month follow-up. Secondary endpoints include target vessel revascularization (TVR), in-stent and in-segment binary restenosis, and late lumen loss (both in-stent and in-segment) as measured by angiography.
William Wijns, MD, of Cardiovascular Center Aalst in Belgium, principal investigator of the trial, said, "While eluting a drug having primarily anti-inflammatory effects, the ProGenic stent offers the opportunity for a next step in improving outcomes in the treatment of obstructive coronary artery disease."
The company said that upon confirmation of favorable results, it will start enrollment of a randomized trial with about 320 patients in 1Q08.
Biotronik's vascular intervention product line consists of guide wires, balloon catheters and stent systems for coronary and peripheral applications.
VivaNet imaging reader group formed
Lucid (Rochester, New York) reported the formation of an association of European diagnostic readers whose objective is to provide image reading services for private European dermatology practices using Lucid's VivaScope in vivo confocal imaging technology.
The company said the VivaScope confocal imagers can non-invasively image skin in vivo with cellular resolution. "This potentially permits pathologic diagnosis without the need to excise tissue," it said.
The European diagnostic readers will validate the procedure utilizing Lucid's VivaNet telemedicine information system to transfer and manage clinical data between the private-practice imaging sites and the locations of diagnostic readers.
The company said the diagnostic readers involved in the association include some of the leading global in vivo confocal imaging medical researchers.
Initial participants in the Association for the VivaNet study include: Dr. Salvador Gonzalez of Ramon y Cajal Madrid , Dr. Giovanni Pellacani of University of Modena and Reggio Emilia, Drs. Josep Malvehy and Susana Puig of Hospital Clinic Barcelona and CEDILP , Dr. Ralph Braun of University Hospital Zurich , Dr. Marco Ardigo of San Gallicano Dermatological Institute , Rome, and Dr. Rainer Hofmann-Wellenhof of Medical University Graz .
The company said it anticipates that additional European medical professionals will join the diagnostic readers' association as confocal imaging technology becomes routine practice in dermatology offices throughout Europe.
Lucid said the diagnostic readers in the association "are skilled in the diagnosis of a wide range of skin diseases including skin cancer, precancerous skin conditions and inflammatory skin diseases"
It added that, since the diagnostic readers operate in the networked environment of the VivaNet, "consultations and second opinions among these experts is straightforward."
The association will launch its pilot activities in September as the initial European confocal imaging sites come online, with full implementation of the association's diagnostic reading services expected to begin by year-2007.
"The availability of [the] VivaNet system should enable the routine use of confocal imaging in dermatology practices," said Jay Eastman, chairman and CEO of Lucid. "It allows dermatologists and confocal diagnostic readers to easily exchange medical information in a secure environment, thus allowing routine collaboration between these medical professionals in difficult to diagnose cases."
He added that in vivo reflectance confocal microscopy "may one day eliminate the need for many routine invasive skin biopsies."
UK distributor for ActiPatch
BioElectronics (Frederick, Maryland) said that Ream Surgical (Dartford, UK) has signed an agreement and issued its initial purchase order for the distribution of the company's ActiPatch Therapy product in the UK. The initial order shipped late last week.
Ream is among an expanding list of international distributors for the ActiPatch Therapy. BioElectronics said it has signed agreements in place and shipping has commenced to Canada, Germany, Kuwait, Mexico, Panama, Singapore and Turkey.
"[We are] pleased to be working with BioElectronics to bring the ActiPatch range of products to the UK. We feel this product will benefit the British public in the overall recovery process and get patients back to normal activities," said Wayne Jarvis of Ream Surgical.
ActiPatch is a drug-free anti-inflammatory patch with an embedded battery-operated microchip that delivers weeks of continuous pulsed therapy, providing what BioElectronics terms "a cost-effective, patient-friendly method to reduce soft tissue pain and swelling."
HCA sells two Geneva hospitals
HCA (Nashville, Tennessee) reported completing the sale of its two Geneva, Switzerland, hospitals, Clinique de Carouge and Hospital de la Tour , to a newly formed affiliate of Colony Capital , a private equity firm specializing in real estate investments.
Terms of the transaction were not disclosed.