A Medical Device Daily

Volcano (San Diego) reported the first human procedure using its Optical Coherence Tomograph (OCT) Imaging catheter in a procedure performed by Patrick Serruys, MD, at the Thoraxcenter (Rotterdam, the Netherlands).

The company said Volcano OCT will complement its existing line of IVUS imaging catheters and pressure guidewires used for coronary imaging and lesion assessment.

A manufacturer of intravascular ultrasound (IVUS), functional measurement (FM) and OCT products designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, Volcano acquired the OCT technology through its purchase of CardioSpectra (San Antonio) at the end of 2007 (Medical Device Daily, Dec. 20, 2007).

The OCT platform provides high-resolution images in the 10-micron to 15-micron range, opening the door, the company says, for new applications to complement both IVUS and angiography.

Serruys said the Volcano OCT Imaging Catheter is "another step closer to delivering interventionalists ... the true cath lab of the future. To better serve my patients, I want the flexibility to select from an array of different tools, quickly interrogate the vessel, and immediately process the information."

He said that having these various technologies including IVUS, OCT and FFR all integrated into the lab, with a common user interface, review points, data storage and staff training provides this flexibility.

Scott Huennekens, president/CEO of Volcano, said, "Our investment in this OCT product line underscores that commitment, and opens a series of new clinical applications and opportunities to complement our existing product line. We are delighted to be under way with our OCT effort just four months after completing the acquisition."

He added: "With our two imaging technologies, we are the leader in intravascular imaging and commercializing this technology will provide us further competitive advantages. We are working on offerings that incorporate OCT functionality into our s5i IVUS platform, as well as stand-alone OCT systems."

Huennekens said his company's emphasis "continues to be focused around choice the ability for Volcano to provide a number of different therapy-enabling modalities, and letting the physician choose which technology is appropriate for each individual patient." He said Volcano's aim is both to complement everyday PCI technique and to "further the understanding of atherosclerotic disease progression."

Clinical-trials company adds DEXA scanners

Synexus (Manchester, UK) said it has "significantly increased" its capacity to recruit and run global osteoporosis trials by increasing the number of DEXA scanners at its hub sites by a third. The DEXA scan is widely believed to be the most reliable way of identifying osteoporosis and is the best test for measuring bone mineral density.

The company said it has complemented its DEXA investment with the provision of heel scanners to hundreds of primary care practices to boost enrollment.

Osteoporosis affects one in three women over 50 and one in five men around the world; increasing to one in two and one in three in the over 60s. It is estimated that the worldwide cost of osteoporosis will increase to $131.5 billion by 2050.

Ian Smith, MD, medical director and founder of Synexus, said, "The heel scan is a quick, easy and cost-effective way of determining whether there is a likelihood of osteoporosis. All the patients who have an elevated reading are then offered a DEXA scan at one of our hub sites in order to make a definitive diagnosis."

CEO Michael Fort added, "We have dramatically increased our capacity in the area of osteoporosis due to demand from our clients. With our network of 14 clinics in the UK, Eastern Europe, South Africa and India, we are able to randomize thousands of patients."

Synexus recruits participants for clinical trials on behalf of pharmaceutical, biotech and contract research organizations. The clinical trials are then run and managed by Synexus at 14 hub sites across the UK, Poland, Hungary, Bulgaria, India and South Africa.

UK's Isogenica buys Finnish firm

Isogenica (Cambridge, UK) said it has acquired the principal assets of the Finnish biotechnology company, Karyon CTT (KCTT), along with securing a £2 million cash investment.

Isogenica will acquire the intellectual property portfolio and the laboratory equipment of KCTT. The Finnish company KC Holding has, in exchange for a £2 million cash investment, received an unspecified number of Isogenica shares.

Isogenica's in vitro display technology, CIS display, provides an effective means of rapidly identifying polypeptides that bind with high affinity and fine specificity to any given molecular target.

CIS display can be applied to the discovery of new antibody, peptide and polypeptide drug candidates, to the discovery of high-specificity diagnostic compounds and to the isolation of target validation and other research reagents, purification and detection reagents.

Isogenica was formed in 2000 to develop and commercialize innovative in vitro molecular evolution technologies. The company has its research facility at the Babraham Research Campus in Cambridge UK.

TransMedics gets boost from HealthLink Europe

HealthLink Europe (Tilburg, the Netherlands), an ISO 13485 medical device support services and distribution company that has been providing European customer service and logistics support to the North American device industry since 1994, said it is working with TransMedics (Andover, Massachusetts) to help the company expand its presence throughout Europe.

TransMedics has developed the world's first commercial, portable, warm blood perfusion system for use in organ transplantation called the Organ Care System, designed to maintain organs in a warm, functioning state outside of the body to optimize function and enable continuous clinical evaluation. As a result, hearts beat, lungs breathe, kidneys produce urine, and livers produce bile.

"HealthLink delivers our product to our customers in the quickest and most efficient manner possible," says Elizabeth Ewaschuk, director of supply chain for TransMedics. "They speak multiple languages, so they can communicate with our customers with ease no matter where in Europe they're located. And when the call comes in, they have our product from their warehouse to our customer as soon as the customer needs it."