A Medical Device Daily

Arobella Medical (Minnetonka, Minnesota) reported receipt of the CE mark for its Qoustic Wound Therapy System for ultrasound-aided wound care.

The system uses what the company terms "a unique, dome-shaped curette tip to apply low-frequency, cavitational ultrasound to wounds."

It said the combination of physical design and ultrasonic energy "gently removes dead and diseased tissue cells, kills harmful bacteria and biofilm, and leaves healthy and pre-healing granulation tissue intact."

The device is FDA-cleared and already on sale in the U.S.

President/CEO Eliaz Babaev, PhD, said the Qoustic Wound Therapy System "offers cutting-edge ultrasound technology several generations ahead of its competitors. We look forward to bringing this device to the international market."

Arobella Medical specializes in low-frequency ultrasound in wound management therapies. Co-founder Babaev has more than 45 years of experience developing, designing and commercializing medical devices that use ultrasound.

CE mark for TheraScreen kit

Personalized medicine company DxS (Manchester, UK) has received CE-mark certification for the TheraScreen K-RAS Mutation Kit (CE-IVD) for use on Roche's (Basel, Switzerland) LightCycler 480 Instrument II, allowing it to be sold for clinical use in the European Union.

The test helps doctors to identify a patient's K-RAS mutation status and response to anti-EGFR therapies for colorectal cancer. DxS also secured a license to provide Roche's LightCycler Adapt Software v1.1 to be used with the TheraScreen K-RAS Mutation Kits. The software allows automated processing of K-RAS mutation status tests for colorectal cancer patients.

LightCycler Adapt Software v1.1 for CE-IVD is a specialized software package for use with the LightCycler 480 Instrument II which provides automated data processing, avoiding manual interpretation and human error.

The software generates data that is compatible with both LIMS (Laboratory Information Management System) and PMS (Patient Management System), and produces the results in a read-only format, ensuring that a patient's results are secure. The software also has a built-in warning system that generates a troubleshooting message if an assay has not been run correctly.

The LightCycler Adapt Software v1.1 for CE-IVD is available for installation in territories where the TheraScreen K-RAS Mutation Kit is available for sale via Roche. These include Europe, Saudi Arabia, South Africa and Australia.

UK sets evidence review on screening

A panel of experts is set to carry out an evidence review to determine whether women under the age of 25 should be routinely screened for cervical cancer, UK Health Minister Ann Keen said recently.

Cervical screening currently starts at age 25 years in England, in line with World Health Organization (Geneva, Switzerland) recommendations and the advice of leading experts in this country including the independent Advisory Committee on Cervical Screening (ACCS).

The Health Minister has asked the ACCS to review the latest available evidence relating to the risks and benefits of cervical screening in women under 25. The review will:

— Consider evidence of the harms and benefits of cervical screening in women aged 20-24 and look at trends in cervical cancer incidence and mortality in women under 25 years in England.

— Consider the likely impact of HPV vaccination on future incidence of cervical cancer and the timescales for any likely effects.

— Assess levels of awareness of cervical cancer and its symptoms especially in younger women 25-34 who are the least likely to take up screening invitations and consider further measures to increase uptake.

— Consider what measures might be taken to improve knowledge and awareness among GPs and practice nurses regarding the appropriate management patients with possible symptoms of cervical cancer.

— Consider whether asymptomatic women under 25 years should have access to cervical screening either as part of a formal program or through informed choice.

The ACCS will consider the latest evidence available, including evidence from the key cancer charities who will be invited to contribute to the review. The board of experts will then recommend whether it is beneficial for women under 25 to be screened.

Keen said, "We are very proud of our cancer screening programs in the NHS, which are internationally recognized as world-class. Cervical screening saves around 4,500 lives every year and we want to ensure that our program remains in the best interests of young women. Experts will review the latest available evidence in this area as well as consider how we can increase awareness of the importance of screening and encourage more women to decide to take up this important service."

The evidence review will be conducted by the ACCS, which is chaired by Professor Henry Kitchener, National Cancer Director Professor Mike Richards and the director of the NHS Cancer Screening Programs, Julietta Patnick.

Cook to appeal German court decision

Cook (Bloomington, Indiana) said that as part of its global effort to protect its intellectual property portfolio, it will appeal promptly an initial ruling by the District Court of D sseldorf, Germany, denying the company's claim that Edwards Lifesciences (Irvine, California) is infringing Cook's German patent for transcatheter valve technology.

Cook filed the action in February 2008, claiming that the Sapien THV valve made by Edwards infringes Cook's German patent. Despite the German court's decision, the company said it remains convinced that the Edwards product infringes Cook's.

"We are confident that the District Court's first instance decision will be corrected on appeal," said Cynthia Kretz, general counsel for Cook. "We believe that the first instance decision relies upon an improper interpretation of our patented technology and remain confident that a proper interpretation encompasses the Edwards product."

She added, "Protecting Cook's extensive intellectual property concerning transcatheter valve technology is a priority to the company's mission, and we will vigorously pursue all options."

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