A Medical Device Daily

Nfocus Neuromedical (Palo Alto, California) reported receiving CE-mark approval for the CardioVasc Stent-Graft and delivery system, a minimally invasive device for treating patients with saphenous vein graft (SVG) lesions from a previous coronary bypass, vessel perforations and coronary artery aneurysms.

The CE mark allows the company to begin marketing the CardioVasc product in the European Union, and indicates that the product complies with the appropriate quality and safety standards.

“We are pleased to be able to offer this valuable option to physicians in the European Union for treating diseased bypass grafts,” said Martin Dieck, president/CEO of Nfocus. “This is an important first step in what we hope to be a series of regulatory approvals in the coming year.”

Saphenous vein graft disease has been a problem facing the cardiologist since the early days of coronary artery bypass graft (CABG) surgery. In CABG surgery, a segment of the patient’s own leg vein (the saphenous vein) may be removed and used to create an artificial conduit to bypass areas of blood flow blockage that have built up in the patient’s coronary artery.

After CABG surgery, the SVG bypass itself may become blocked over time by the same type of disease that affected the patient’s original coronary artery. The result is a need to reopen the diseased SVG vessel and restore flow. This second treatment again can be yet another surgery — or alternatively, the SVG may be treated via angioplasty and stenting procedures using less-invasive endovascular techniques.

The CardioVasc Stent-Graft device is a permanent implant delivered via a less-invasive catheter procedure for patients that have a diseased SVG from a previous CABG surgery.

The CardioVasc product is not approved in the U.S.

Nfocus is focused on treating hemorrhagic stroke, with product development programs aimed at rapid treatment of aneurysms and fistulas in the brain.

First orders for Cytori’s Celution system

Cytori Therapeutics (San Diego) reported receiving its first orders from Europe and Asia for Celution 800 Systems. The devices are now being sold into the growing international reconstructive surgery market.

The system provides physicians with a rich source of a patient’s own adipose tissue-derived stem and regenerative cells at the bedside. When these cells are re-combined with more of a patient’s own fat tissue in the same surgical procedure, it is referred to as cell-enhanced reconstruction.

Eleven Celution 800 Systems and related CT-805 single-use consumables were ordered by Cytori’s distributors, MBA Grupo, which covers Spain, Italy and Portugal, and Astrea International, which covers Singapore. The first devices are expected to be delivered during the present.

“These opening orders mark a key transition for the company and its products,” said Cytori CEO Christopher Calhoun. “We achieved our stated goal from last year, which was to accelerate our product introduction to early 2008 by bringing an innovative reconstructive surgery product to physicians and their patients.”

Cytori has regulatory approval for the Celution 800 System in Europe, is seeking clearances in the Asia-Pacific region, and has forged commercialization partnerships with distributors in these markets.

The company said it is working with its distribution partners and physicians “to educate the market about this technology in order to extend its penetration.” It said clinical trials are ongoing with the Celution 800 to broaden its utility for multiple applications.

“There is strong receptivity among oncologic and reconstructive surgeons for [the] Celution 800 System, and we are now moving forward with targeted sales,” said Paul Griffin, vice president of international sales and new business development for MBA Grupo.

Noting that the demand is due in part to “recent reports from successful clinical reconstructive surgery cases,” he added: “This product line has the potential for significant growth, as it is addressing an important, unmet medical market.”

The Celution 800 System is being introduced in Europe into the reconstructive surgery market, while the Celution 900 System will be launched in Japan for cryopreserving a patient’s own stem and regenerative cells.

The company said clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs.

Collaboration on HistoScanning

B-K Medical (Copenhagen, Denmark), a wholly owned subsidiary of Analogic (Peabody, Massachusetts), and Advanced Medical Diagnostics (AMD; Waterloo, Belgium), a developer of computer-aided solutions to improve the diagnostic interpretation of ultrasound scans, reported the signing of a collaboration agreement under which they will deploy AMD’s HistoScanning tissue characterization technology for the prostate.

HistoScanning is a tissue differentiation, visualization and measurement technology designed to assist specialists in identifying changes to solid organ tissues. The technology works in conjunction with transrectal ultrasound procedures and extracts new information from prostate ultrasound data.

The companies said it adds “an important new dimension to the practice of prostate examination as well as prostate biopsy indication and acquisition.”

Michael Brock, president of B-K Medical, says, “HistoScanning has the potential to be the major diagnostic modality of the future, increasing the efficiency and diagnostic value of prostate ultrasound.”

Advanced Medical Diagnostics said the agreement facilitates introduction of its technology to major global markets. CEO Dror Nir, inventor of the HistoScanning technology, said, “We want to make sure that HistoScanning will realize its potential. It means working together with companies who share our vision of noninvasive tissue characterization and are committed to investing in moving medicine forward.”

The first joint presentation of HistoScanning will be at the European Association of Urology congress in Milan, Italy, March 26-29. HistoScanning for the prostate is expected to be commercially introduced in Europe later this year.