A Medical Device Daily
Tepnel Life Sciences (Manchester, UK/Stamford, Connecticut) reported the launch of a DNA test for the early detection of familial hypercholesterolemia (FH), a genetic condition that predisposes individuals to high blood cholesterol levels and increased risk of cardiovascular disease.
The CE-marked Elucigene FH20 kit, validated for in vitro diagnostic use, can rapidly determine the 20 genetic mutations most commonly found in a UK-based population, that are responsible for the disease.
The company said the launch comes just prior to the expected release of clinical practice guidelines on familial hypercholesterolemia by the UK's National Institute for Clinical Excellence (NICE).
Tepnel said FH is a public health problem throughout the world, with an estimated 10 million people affected, the majority of who will suffer an adverse coronary event before they are 65 years old.
A common genetic disorder, the potentially lethal condition occurs in one of 500 people in Europe and North America. In the UK, it is estimated that up to 110,000 people are affected with FH and 75% of these cases are undiagnosed.
The NICE consultation on a draft of guidelines for use by the National Health Service (NHS) in England and Wales is being finalized, with anticipated publication shortly. NICE is expected to recommend that all FH patients be offered a DNA test, with subsequent cascade screening to be performed where the mutation is identified in a patient.
Following the confirmation of mutation status of an FH patient using the Elucigene FH20 assay, the Tepnel test can be used to detect other previously undiagnosed family members with FH through cascade screening programs.
In a recent UK pilot study, the test identified a 52% mutation detection rate in a sample of 110 FH heterozygous patients. "The study findings validate Elucigene FH20 as a valuable component for future FH screening programs in the United Kingdom, providing a cost-efficient and simple method for confirming a person has inherited this deadly condition," said Tepnel CEO Ben Matzilevich. "For effective treatment, early identification of persons with FH is essential and FH20 offers the NHS the right tool at the right time to implement the new clinical practice guidelines."
The company said that pre-symptomatic identification of FH individuals "can ensure the health risks of high cholesterol are minimized through appropriate modifications to diet and lifestyle."
CE mark for LTC's Bipolar Forceps
Live Tissue Connect Technologies (LTC; Santa Barbara, California) reported CE-mark certification for its Bipolar Forceps by its Notified Body, BSI Product Services.
Receipt of the CE mark allows LTC to market the forceps with the previously CE-marked VAD.400 generator within the 30 countries of the European Economic Area and Switzerland.
The LTC Bipolar Forceps consist of two configurations of disposable instruments that are used exclusively with the LTC VAD.400 generator. Its intended use is for the application of electrosurgery in general surgery and gynecological procedures for the sealing of arteries, veins and ducts.
The company said the Bipolar Forceps system is an alternative to mechanical clamping via clips or staples, and suturing, and can be used on veins and arteries up to 7 mm diameter, on ducts up to 2 mm diameter and on tissue bundles as large as will fit between the jaws of the instrument.
LTC President Frank D'Amelio said, "We have set forth an aggressive schedule for commercialization of LTC's technology and we continue to execute against that plan. Potential dealers have expressed much enthusiasm for our technology and the opportunity to join the LTC sales team."
LTC Technologies, a subsidiary of CSMG Technologies (Corpus Christi, Texas), previously received 510(k) clearance from the FDA for both the generator and forceps.
Merger application proposal withdrawn
TUV Rheinland of North America (Newtown, Connecticut) said that its parent company, TÜV Rheinland, has withdrawn its application to merge with TÜV SÜD.
The companies said they have withdrawn their merger application from Germany's Federal Cartel Office after determining that the proposal would not have met current antitrust requirements in Germany.
TÜV Rheinland and TÜV SÜD said they plan to reapply for a merger with a new business solution that meets the German government's strict antitrust requirements.
Officials from both companies said they believe the eventual merger will create "an ideal dynamic." They said that together, the two companies "have the potential to successfully mine the inspection, testing and certification markets and create new jobs in Germany while facing strong international competition."
"Both companies feel very strongly that a merger is a good decision, and it would have a positive impact on our operations right here in North America," said TUV Rheinland of North America's President/CEO Stephan Schmitt. "Combining our North American operations would further expand our resources and improve our competitive stance. Our companies have made so much progress in the path toward a merger, we are confident a solution can be created for a successful application."
TÜVRheinland is the world leader in independent testing and assessment services. The $1.5 billion company is comprised of an international network of more than 12,500 employees at some 360 locations in 62 countries.
Swemed Sense needle gets CE mark
Vitrolife (Kungsbacka, Sweden) said it has received the CE mark for its new Swemed Sense needle for the collection of human oocytes. The company said the needle, which is in commercial launch, has received "very positive response."
"This is the first product that applies a new technical principle for oocyte collection needles," said Tony Winsl f, marketing director.
The Swemed Sense needle is designed with a thinner front part and tip so as to minimize tissue damage, bleeding and pain, while the rear part of the needle has a larger diameter that makes the needle more stable during the collection process.
Vitrolife said it has filed patent applications for Swemed Sense in all major markets.