A Medical Device Daily
Cinvention (Weisbaden, Germany) and Relisys Medical Devices (Malakpet, India) reported enrollment of the first patients in the COREL drug-eluting stent trial.
COREL is a prospective, open-label, randomized clinical trial that will enroll 150 patients in 10 centers in India. Enrollment in the study will be carried out through 10 clinical trial centers in Ahmadabad, Bangalore, Chandigarh, Hyderabad, Mumbai, New Delhi and Vellore.
Principal investigator of the study is Balram Barghava, MD, of the All India Institute of Medical Sciences (New Delhi).
The primary endpoint is nine-month in-stent late loss within the stented segment post-procedure and historical comparison with six- to nine-month in-stent late loss with other drug-eluting stents.
Secondary endpoints include angiographic binary restenosis, target lesion revascularization, target vessel revascularization and target vessel failure rates at nine months; major adverse cardiac events; acute, sub-acute and late stent thrombosis at 30 days and nine and 12 months; lesion, device and procedure success.
Relisys' Corel + C drug-eluting stent includes a cobalt-chromium stent that is coated with a macro-porous, nano-structured, carbon-composite matrix containing the active drug paclitaxel. Developed and provided by Cinvention, the coating eliminates the use of polymers and provides a bioactive coating with less thrombogeneity and pro-endothelialization surface design, which the company said reduces tissue inflammation and reaction, while enhancing engraftment and endothelialization.
Bhargava said he expects "significant improvements" in short-, mid- and long-term clinical outcomes.
"This is the first time that a nano-structured coating is used as an elution platform," he said. "We are confident that this trial will … demonstrate that the non-polymeric, bioactive, nano-composite coating will reduce the late thrombosis issue significantly."
Dr. Soheil Asgari, CEO and chief technology officer of Cinvention, said enrollment in the trial would be completed quickly. "The investigators community has access to a large collective of patients and we expect the stenting of the patients within four to five weeks."
He added: "The Cinvention coating replaces inflammatory polymers — either durable or absorbable — by the most inert material known, carbon. [Our] technology enables the embedding of drug control properties together with a surface design that attracts endothelial cells and allows attachment and proliferation on the nano-structured surface"
Badari Narayan, managing director of Relisys, said he expects "a clear result demonstrating the superior performance of the Corel + C stent," because of "unique advantages."
He added, "While other companies are still in the early development phase of non-polymeric stents, Relisys has gained a head start over the community. We combine the advantages of a cobalt chromium stent with an excellent profile and deliverability, together with the proven drug paclitaxel and the most advanced coating platform."
Narayan said the Corel + C stent "was designed to eliminate the potential complications of thrombosis that are now identified as the main issues of drug-eluting stents."
Healthtronics, EDAP dissolve relationship
EDAP TMS (Lyon, France) and HealthTronics (Austin, Texas) said they have entered into an agreement to formally terminate an agreement relating to U.S. clinical trials of EDAP's High Intensity Focus Ultrasound (HIFU) technology.
Under terms of the agreement, EDAP regains full rights for its Ablatherm-HIFU prostate cancer therapy device in the U.S. market, pending future FDA approval.
In addition to the termination of the original distribution agreement with EDAP, HealthTronics exercised warrants to acquire 200,000 EDAP shares for $300,000 and agreed to return to EDAP two Ablatherm devices used in connection with the clinical study, both of which were already owned by EDAP, and one Ablatherm device and six lithotripters previously acquired from EDAP.
EDAP also agreed to register with the Securities and Exchange Commission, at its expense, the resale of the 200,000 EDAP shares or related American Depositary Shares acquired by HealthTronics.
HealthTronics also agreed to pay EDAP $600,000 in the future and may have to pay EDAP additional amounts based on a formula related to the price at which HealthTronics resells the EDAP shares.
Sam Humphries, president/CEO of the U.S. firm, said, "We are very pleased to transition the clinical study to EDAP. As I had previously discussed in the fourth quarter of 2006, the termination of our relationship with EDAP is part of our restructuring and cost-reduction initiatives implemented in 2006, as well as the redefinition of our long-range strategy."
Hugues de Bantel, who is in charge of the U.S. FDA programs for EDAP, said, "We look forward to immediately resuming the approved IDE [investigational device exemption] program. Our centers are fully trained and actively recruiting for this important study. We are adding more centers as doctors become aware of HIFU's global experience and want to participate in evaluating it for the U.S. clinical study."
CRO names Phase Forward preferred partner
Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, reported that SGS Life Science Services (Geneva, Switzerland), a contract research organization, has selected it as a preferred partner.
SGS Life Science Services will use Phase Forward's InForm electronic data capture (EDC) product to support the data collection, management and analysis for clinical trials.
The selection of the InForm product as SGS' preferred EDC system marks an expansion of SGS Life Science Services' relationship with Phase Forward, the company said. SGS uses Phase Forward's Clintrial product, a comprehensive clinical data management and analysis system that integrates both electronically captured and paper-based study data, as well as Phase Forward's Clintrace software, a highly scalable, adverse event tracking and reporting system.
The InForm solution supports thousands of trial sites with near real-time data, providing end-to-end clinical development capabilities designed to improve trial safety, efficiency and cost-effectiveness. While SGS Life Science Services has extensive experience with the InForm software through externally hosted customers, this agreement allows SGS to offer the EDC system as an integral part of the SGS solution set, according to the company.