A Medical Device Daily

bioMérieux (Paris) reported the launch of its NucliSENS EasyQ HPV, a molecular diagnostic test that enables the detection of human papillomavirus (HPV) in cervical cancer surveillance.

NucliSENS EasyQ HPV is the result of the partnership between bioMérieux and NorChip. It uses NorChip's PreTect HPV-Proofer and bioMérieux's NASBA Real-Time technologies.

The companies said that most cervical cancer surveillance methods currently in use today detect viral DNA. But such testing, they said, does not make it possible to most effectively assess the virus' oncogenicity. Developed by bioMérieux, NucliSENS EasyQ HPV is based on a new concept that directly determines the expression of oncogenic risk factors by detecting the mRNA of the E6 and E7 proteins.

bioMérieu said the test's high added medical value has been showed in a number of recently published papers. "It enhances the quality of women's lives by reducing the need for invasive examinations and treatments," the company said.

"This new molecular diagnostic test reinforces bioMérieux's offer in the field of oncology," said Stéphane Bancel, bioMérieux CEO. "The test contributes to the fight against cancer and complements current methods for the detection and monitoring of cervical cancer."

According to bioMérieux, NucliSENS HPV EasyQ is the first real-time amplification/detection test with this degree of automation to be CE-marked. It is currently available in France, the Netherlands, Belgium, Switzerland, Spain and Austria, and will be progressively marketed in other countries, the company said.

FulFil implant receives CE mark

Evera Medical (Foster City, California), maker of FulFil, a saline-filled implant for tissue augmentation, said it has been granted the CE mark. FulFil is used for facial soft tissue augmentation, with the first product in the line being a saline-filled lip implant for permanent reversible enlargement.

Michael Lesh, MD, CEO and chairman of Evera, said, "The market for facial augmentation, especially lip enhancement, is large and growing. Our clinical data showed that the physicians who have implanted FulFil, and the patients who have been treated, are very satisfied with the results."

Evera said that Lucy Glancey, MD, a cosmetic surgeon practicing in London, is the first in the EU to treat a patient after Evera received CE-marking. "This implant represents a significant improvement over existing products such as temporary dermal fillers and facial implants made of stiffer synthetic material," she said.

The FulFil implant is constructed of a special multilayer polymer membrane. During patient treatment, it is filled with saline, which can be added or removed until the desired degree of enhancement is achieved. Evera said that currently marketed lip implants can heal with excessive scarring, resulting in discomfort and stiffness, while areas treated with the implant remain soft.

Augmentation is permanent, reversible and patient outcomes are predictable, according to the company. More than 200 patients have been treated worldwide, 50 of whom have been followed for more than a year. FulFil is available in a number of sizes to accommodate a range of treatment areas.

Evera, formerly Juva Medical, manufactures the FulFil implant for soft tissue augmentation outside of the U.S. In the U.S., clearances for a range of applications are pending with the FDA.

Arrow to distribute Esaote system

Arrow International (Reading, Pennsylvania), which describes itself as the world's leading provider of central venous catheter (CVC) products, reported that it will distribute on an exclusive basis in the U.S. and Canada a new Hand-Held Ultrasound System for vascular access produced by Esaote (Genoa, Italy).

Arrow said the InView Ultrasound System will complement the Maximal Barrier Precautions CVC and Pressure Injectable PICC kits, access products it has introduced recently.

It said the InView's features and robust design will provide clinicians with a cost-effective, easy-to-use ultrasound guidance system to assist in the placement of vascular catheters.

"The addition of the InView Ultrasound System to our venous access product range is a step in broadening our product portfolio to include the tools clinicians require for the accurate placement of CVCs and PICCs," said Rick Eagle, vice president, venous access, at Arrow International. "Esaote has a strong technology base in diagnostic ultrasound [and] there are many joint marketing opportunities that our companies are evaluating."

Claudio Andreucci, ultrasound and ECG manager for Esaote, described the collaboration with Arrow as "a strategic step for increasing the capacity of the Esaote Group to develop ultrasound units dedicated to innovative clinical applications, which can improve and simplify the clinician's daily activities."

More data on CryoCath's Arctic Front

CryoCath Technologies (Montreal), a developer of cryotherapy products to treat cardiovascular disease, said that additional data on its Arctic Front catheter system to treat atrial fibrillation (AF) was presented at the annual conference of the German Cardiac Society (D sseldorf, Germany) in Mannheim earlier this month.

CryoCath sponsored a cryotherapy symposium featuring presentations by Dr. Julian Chun and Dr. Matthais Antz of Asklepios Klinikum St. Georg (Hamburg, Germany) Professor Burghard Schumacher of Rhon-Klinikum (Bad Neustadt) and Professor Luc Jordaens of Erasmus Thoraxcentre (Rotterdam, the Netherlands).

The clinicians presented acute and three-month data on a total of 150 patients following ablation procedures. Acutely, more than 90% of the pulmonary veins were successfully isolated. When pulmonary vein isolation was achieved, 75% of patients were AF-free after three or more months following a single procedure, CryoCath said.

No stenosis, thrombosis, esophageal perforation or stroke were reported at any of the centers, and no left atrial flutters, a common occurrence following RF ablation procedures, were observed.

"This European data demonstrates that Arctic Front is a practical tool for the treatment of AF in a typical EP lab setting," said Jan Keltjens, president/CEO of CryoCath. "It demonstrates that it is feasible to isolate pulmonary veins in a very high percentage of cases using Arctic Front alone."

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