Medical Device Daily
and Staff Reports

Introduction of improved product, physician training and marketing, sales – the standard drill for device commercialization. And one other thing. Start in Europe.

That's the trailCardica (Redwood City, California) is climbing with recent announcement of CE-marking for its C-Port xA Distal Anastomosis System for venous and arterial indications.

The C-Port xA system is the next generation of Cardica's C-Port system, which automates the attachment (anastomosis) of a bypass graft vessel and target artery downstream of the narrowed or occluded coronary artery in coronary artery bypass graft (CABG) procedures.

In sum, Cardica is continually positioning itself to replace hand-sewn suturing with its automated devices, these devices requiring higher up-front costs but providing speedier attachment and improved patency, all factoring out to much-reduced downstream costs, Bernard Hausen, MD, PhD, president and CEO of Cardica, told Medical Device Daily.

The company has first focused on anastomeses of vein grafts of 4-6 mm in diameter with its devices, but improvements to the company's C-Port X system – voila, the xA device – enables automated suturing of arterial grafts as small as 1 mm in diameter.

Hausen noted that the improvements importantly include a change from a spring-based mechanism for deployment to a CO₂ cartridge, providing a much-increased sensation of ease for the surgeon, and he noted that a key effort of Cardica is to develop “tools to match expectations.”

Other changes include improved access to the coronary artery and reduction of target site preparation; improved staple configuration; and incorporation of vessel clamps for ease of loading the graft vessel for anastomosis. The C-Port xA is designed to deploy staples around the periphery of the anastomosis to help ensure leak-proof sealing and enabling expansion and contraction with blood flow.

The C-Port X system previously was CE-marked, but Hausen said the company has not distributed it in Europe yet. Now, the xA device will be marketed through a new Italian distributor and sold in “select” European countries in a controlled roll-out.

The metrics of that sale present a fairly typical exercise.

The device costs about $1,000 (less with volume purchases), significantly more than hand-suturing, but compared to 10 minutes per hand suture, Cardiac's systems can do it in a few seconds and have been shown to produce superior connection via comparison of patency data.

Hausen compares the technology to past and present anastomoses for the bowel, with which he is most familiar as a surgeon.

The bowel stapler, he noted, was introduced in 1991 and “at that time, we rejected it as initially more expensive than sutures and not using the skill sets that surgeon typically employed. But the results were so reproducible – one surgeon to the next, and so quick – now, despite the additional cost 95% of all bowels are attached using stapling devices.”

Hence, for the company's devices, “There's no reason that same model won't apply,” he said.

Cardica has already pushed this paradigm in the U.S. market with FDA and international clearances of its vein grafting systems, and the company is currently awaiting FDA clearance of the xA.

Meanwhile, Hausen said Cardica is pushing ahead with development of systems that will be usable for the increasingly numerous, less-invasive procedures in the cardiovascular sector with what it calls its FlexA system. That system, he reports, is currently in the preclinical phase.

Czura Thornton acquires Chiltern International

Czura Thornton (London) reported that it has acquired Chiltern International (Slough, UK/Carlsbad, California), an independent clinical contract research firm, for an undisclosed sum.

Czura Thornton, a private investment group led by Antony Czura and Nick Thornton, acquired more than 90% of Chiltern, with the remainder expected to be acquired “over the next few weeks.”

Chiltern – with offices in Europe, India and the U.S. – runs international Phase I-Phase IV clinical trials across a range of therapeutic categories. It provides Clinical Operations, Project Management, Bio-analytical, Data Management, Biostatistics, Medical Writing, Quality Assurance and Regulatory and Medical Affairs services to the medical device, biotech and pharma sectors and clinical contract personnel services to pharma and biotechnology clients.

Simon Garnham, co-founder of Chiltern, will step down as CEO and Nick Thornton, who becomes executive vice chairman, also will act as chief executive. Roland Boyd has been appointed CFO.

Established in 1982, Chiltern is one of the largest independent contract research organizations in the world employing more than 750 people, with locations in the UK, France, Germany, Italy, Spain, Poland, the Czech Republic, Ukraine, India, South Africa and across the US.

Sören Mellstig to leave as Gambro president/CEO

Gambro reported that Sören Mellstig will resign from the positions of president and CEO but provide assistance through a transitional period.

Jan Bruneheim has been appointed the new president and CEO, taking over those positions on Aug. 2. Bruneheim most recently was president/CEO of the Telefos Group.

Gambro is a provider of renal care services and products and blood component technology.

austriamicrosystems new IC supplier to Siemens

austriamicrosystems (Unterpremstaetten, Austria), a developer of analog integrated circuits (IC), said it will supply Siemens Medical Solutions with detector electronics ICs for the platform of its newest computed tomography (CT) system Somatom Definition. austriamicrosystems said the partnership and related process development results “in the world's most innovative computed tomography detection electronics to be used in current and future image processing systems from Siemens.”

austriamicrosystems' optical interface readout IC acquires signals in real-time and digitizes them for improved image resolution and speed. A Siemens system may comprise more than 1,000 austriamicrosystems ICs with the scale of integration required by the high number of measurement channels.

Dr. Bernd Ohnesorge, vice president, Global CT Marketing and Sales at Siemens Medical Solutions, said, “Taking advantage of austriamicrosystems' unique expertise in designing maximum performance analog ICs, we were able to set a new trend in CT technology with this new generation of detector electronics.”