A Medical Device Daily

Cardica (Redwood City, California) reported last week that it has received CE mark approval for its C-Port Flex A anastomosis system. The C-Port Flex A system is a variation of Cardica’s C-Port xA Distal Anastomosis System product line and further facilitates the automated anastomosis, or attachment of blood vessels and grafts, during less-invasive coronary artery bypass graft (CABG) procedures.

The company said two independent groups of cardiothoracic surgeons in the U.S. recently performed minimally invasive, closed-chest bypass procedures using the C-Port Flex A anastomosis system and Intuitive Surgical’s (Sunnyvale, California) da Vinci surgical system.

“We are pleased that the European authorities have approved the use of the Flex A. We continue to receive positive feedback from cardiothoracic surgeons in the U.S. who are using the C-Port Flex A to perform ground-breaking closed- chest and beating heart procedures,” said Bernard Hausen, MD, PhD, president/CEO of Cardica.

He added that the C-Port Flex A “is designed to enable surgeons to create compliant, reliable anastomoses in sternum-sparing bypass procedures, even in difficult to reach areas of the heart.”

The C-Port Flex A system features several modifications to Cardica’s C-Port xA system, which is designed to enable automated, reliable and reproducible connections of blood vessels during CABG surgery. The C-Port Flex A system has a flexible, rather than rigid, shaft; is effective in creating compliant anastomoses in vessels as small as one millimeter in internal diameter; and, can be used in either on- or off-pump CABG procedures.

The company said the flexible shaft allows surgeons to position the device to create a secure connection even in difficult to reach areas of the heart. The Flex A received 510(k) clearance from the FDA in March.

“We believe the C-Port Flex A system brings us several steps closer to the possibility of performing truly minimally invasive cardiac surgery with significant benefits for the patient due to less trauma and a faster recovery time compared to a traditional open heart bypass procedure,” said Stefano Demertzis, MD, PhD, senior cardiac surgeon at Cardiocentro Ticino (Lugano, Switzerland).

Nucletron completes management buyout

Nucletron (Veenendaal, the Netherlands) said it has completed its management buyout from Delft Instruments (Delft, the Netherlands), creating an independent company dedicated to radiation oncology. Nucletron has operated several entities in the field of radiation oncology. It said the consolidation of the various entities into a single focused company further establishes its leadership role in the field.

The company said partnerships, pioneering research and development of advanced technological innovations will enable it to “more effectively deliver cancer treatment solutions globally.”

The supervisory board of Nucletron will be chaired by Rob Westerhof, who has held senior positions in Asia and the U.S. for Philips Medical Systems and Royal Philips Electronics. Westerhof said, “Nucletron represents a strong brand in the world of oncology and related areas, and there are excellent opportunities for expanding our market share.”

“The creation of an independent Nucletron is the result of the company’s success in the past two years,” said CEO David Imperiali. “Nucletron has a strong tradition of innovation in radiotherapy, and the breadth of our capability positions the company well to continue to make significant contributions to the treatment of cancer.”

The previous company, under Delft Instruments, was created by merging Nucletron, a brachytherapy solutions company, with the Oldelft Simulix brand of radiation therapy simulation and imaging technology. In 2003, Nucletron integrated the Helax and Theratronics treatment planning and management solutions from MDS Nordion (Ottawa) into its portfolio to create Oncentra MasterPlan and Oncentra Information Management.

“Nucletron’s ability to restructure itself, anticipate needs, and incorporate new products and services into our solutions suite gives us the ability to create strong and long-lasting relationships with our customers and partners,” said COO Jeroen Cammeraat.

More than 10% of the company’s revenues are invested in research and development. It said its R&D program, both in-house and through partnerships with major academic institutions, “has resulted in a strong and unique IP base.”

Nucletron delivers customized solutions to more than 3,000 institutions in more than 120 countries, with annual sales of $160 million. It has offices in 16 countries, including a production and R&D facility in the Netherlands, R&D centers in Uppsala, Sweden, and Oslo, Norway, and sales, marketing, service and support operations in Europe, Asia, Australia and North America.

Accord signed on breast-cancer test

bioM rieux (Marcy L’Etoile, France) and Ipsen (Paris) said they have signed an agreement in which bioM rieux will develop a companion test for a new breast cancer drug undergoing clinical evaluation by Ipsen.

The development will be co-funded by bioM rieux and Ipsen.

Ipsen is developing a breast cancer therapy, BN 83495, targeting the steroid sulfatase enzyme (STS). The new drug, designed to block this marker found in hormone-dependent breast cancer in postmenopausal women, is currently in Phase I clinical development.

bioM rieux will devise a companion assay to determine the patients best suited to benefit from the new STS inhibitor treatment. The assay is intended for both the clinical development of the Ipsen drug as well as a diagnostic test, potentially for future commercialization.

The test will be developed on bioM rieux’s NucliSENS EasyQ molecular diagnostics platform, using the company’s NASBA amplification technology.

St phane Bancel, bioM rieux CEO, said, “bioM rieux is pleased to sign an important theragnostics partnership with Ipsen and bring a high-medical-value test to help advance cancer treatment options and improve patient prognosis.”

Jean-Luc B lingard, chairman and CEO of the Ipsen Group, said, “This innovative collaboration with bioM rieux is designed to help Ipsen accelerate the time-to-market of its potent steroid sulphatase inhibitor compound BN 83495, bringing, as soon as possible, its therapeutic benefits to those breast cancer patients showing potentially responsive clinical profiles.”