A Medical Device Daily
Enrollment has begun in CABG Medical’s (Minneapolis) clinical trial for CE mark approval of the Holly Graft System, a drug-eluting graft (DEG) for facilitating a coronary artery bypass procedure.
The implant of the graft system in the first patient enrolled in the clinical trial – the second patient treated with the system – was completed by Peter Tesar, MD, and Trevor Fayers, MD, at Prince Charles Hospital (Brisbane, Australia). The two surgeons also completed the first implant of the Holly Graft System last November.
The Holly Graft System is designed to treat blockages in multiple coronary arteries from a single graft. The Holly system consists of a flexible, thin-walled vascular graft made of expanded polytetrafluoroethylene; it is attached to the coronary arteries via connectors coated with a drug combination to reduce the risk of blockage and thrombosis.
The major benefit of the system is to eliminate a secondary surgery conducted as part of a heart bypass procedure to harvest healthy vessels from the chest, legs or arms for use in the bypass, the company said.
Well-known med-tech entrepreneur Manny Villafana, who is chairman and CEO of the company, said, “We have worked closely with our scientific advisory board and our physician collaborators over the past four years in developing a technology that had a safety profile that was adequate to move into human evaluation.”
He said the incorporation of a paclitaxel drug into the system “has made a profound difference that could positively impact the effectiveness of the device.”
Noting that the CE mark is the designation for approval in major markets outside the U.S. and Japan,” Villafana said, “We are excited to begin this important work with some of the most prominent cardiac surgery centers in the world.”
CABG Medical raised more than $30 million in an initial public offering of some 5.5 million shares late last year (Medical Device Daily, Dec. 9, 2004) and subsequently added another $4.5 million through sale of an additional 825,000 in the exercise of over-allotment options.
Agilent to broaden efforts in India
Agilent Technologies (Palo Alto, California) last month reported plans to introduce its DNA microarray-based genomics solutions into India’s growing life sciences market.
The company currently sells technologies for the biotechnology, chemical, environmental and pharmaceutical manufacturing markets in India, and said it expects to expand its presence into industries such as medical research, drug discovery and agro-biotech.
“Agilent’s Life Sciences and Chemical Analysis [LSCA] business had double-digit growth in India last year, driven by the country’s booming biotechnology, agriculture, information technology and pharmaceuticals industries,” said Sanjeev Dhar, country manager for the LSCA business in India. “India is now LSCA’s fourth-largest country of business in Asia, and one of the fastest-growing. We expect this growth to continue as we launch our solutions for the life sciences sector into areas such as genomics and proteomics research.”
Genomics and bioinformatics company Genotypic has estimated that the Indian microarray market will grow by some 70% this year.
“Growth in sectors like biopharmaceuticals, contract research bioservices, agriculture, genetic engineering and molecular medicine will drive growth for analytical instrumentation,” Dhar said.
Agilent’s initial plans focus on introducing its DNA microarray-based genomics solutions, which improve the productivity of gene-expression and genomics research.
MSI reports on added initiatives
Medical Services International (MSI; Edmonton, Alberta) said it has been asked to start supplying its VScan HIV 1 & 2 test kits in China by the end of this month.
The company had earlier reported a contract with China to start supplying VScan HIV test kits in July 1. It now has been asked to supply 315,000 HIV test kits by May 30, as well as additional kits in June.
The contract with China is to supply $25.5 million in VScan HIV test kits over three years.
Medical Services International also reported that regulatory authorities in Peru have asked it to send the necessary kits and documentation to begin the approval process for the VScan hepatitis B test kit.
The company reported earlier that it had received approval for its VScan HIV test kit in that country.
Based on current negotiations, it said that Peru would need about 200,000 HIV test kits every two months, for a total of 1.2 million such kits per year. The VScan test kit is the only HIV test kit approved by regulatory authorities in Peru.
MSI also said that it has been approached to supply VScan HIV, hepatitis B and TB test kits to Chile. It said it expects to begin the necessary testing for regulatory approval in Chile very soon, and estimated a need for up to 500,000 HIV rapid test kits per year that can be used in remote areas and that require no refrigeration or medical facilities.