A Medical Device Daily

Scientists at the University of St. Andrews (St. Andrews, Scotland) reported yesterday that they have won a £750,000 grant to develop a new "super" microscope to be used for cutting-edge research into Alzheimer's disease and cancer.

The Biophotonics workstation will be the first instrument of its kind to offer a wide range of functions for cell research in a single tool, the university said in a statement. It will allow scientists to image, sort, separate and punch holes into cells as small as 1/100th of a millimeter.

The work, it said, "will have a crucial role to play in developing technology for the early diagnosis and treatment of a range of illnesses."

The project will draw together research at the university from academics including physicist Professor Wilson Sibbett, cancer researcher Andrew Riches, and Frank Gunn-Moore, a neurobiologist investigating how nerve cells are affected by neurodegenerative diseases such as Alzheimers.

Leading the project is Professor Kishan Dholakia, head of the Optical Trapping Group at the School of Physics and Astronomy. Dholakia is pioneering a number of cell-based research techniques based on light.

Of the recent funding, supplied by the Engineering and Physical Sciences Research Council (EPSRC), he said: "Standard microscopes can usually do one or two things, but this biophotonics workstation will offer the whole range of functions in a single tool. It will combine the latest advances in optics with some really cutting edge biology and ultimately could help save lives."

The multi-disciplinary aspect of the work station means research will benefit from added safety against possible contamination to cells.

Gunn-Moore said: "Since all of the functions [of the workstation] can be done in one room and on one system, our cell samples involved in Alzheimer's disease or cancer don't have to be moved – thus minimizing the possibility of contamination and ensuring the stability of tissue."

The workstation, which will take two years to put together, will be built around a Nikon microscope and will use compact lasers. It is expected to be the size of a 20-inch television, but the researchers said they could develop smaller versions, depending on commercial interest.

Dholakia said: "We own the intellectual property on this project and if the initial microscope is a success there is lots of potential to build bespoke microscopes for other research organizations or medical diagnostics companies."

CE mark sought for CardioPass

CardioTech International (Wilmington, Massachusetts) said it has submitted to its European Notified Body an application to obtain CE marking for its CardioPass Artificial Coronary Artery Graft.

The initial indication will be for use in treating "no-option" patients in need of coronary artery bypass but do not have enough of their own native vessels for the necessary revascularization. These patients, CardioTech said, frequently have native vessels, including saphenous veins, radial arteries and mammary arteries, which have been used in previous bypass surgeries or are too diseased to be utilized due to diabetes or other diseases.

In preparation for CE-marking submission, CardioTech obtained ISO 9001 and ISO 13485 certification in its Wilmington facility in November of last year.

Michael Szycher, PhD, CEO and chairman of CardioTech, said, "There are currently thousands of 'no-option' patients who could benefit from the use of our CardioPass graft." The CE mark, he said, also will "expedite approvals everywhere in the world, except the United Sates and Japan."

Szycher added: "Firstly, the CardioPass graft is fabricated from our patented ChronoFlex biodurable poly-carbonate urethane. Secondly, the graft is compliant and pulsatile, and thirdly is microporous to allow tissue in-growth and encourage the formation of a stable neointinal lining, the end stage of the healing process." He said that these characteristics make the company "optimistic that CardioPass will be the first clinically successful synthetic coronary bypass in the world."

CardioTech's revenues come from the sale of biomaterials, original equipment manufacturing and the manufacture of devices for cardiopulmonary bypass. Its wound dressings address a $600 million annual market. CardioTech also is developing a synthetic coronary artery bypass graft that addresses a potential market of $1.5 billion annually.

EDAP TMS lauds HIFU acceptance

EDAP TMS (Lyon, France) this month lauded the recent guidelines published by the UK's National Institute for Clinical Excellence (NICE) supporting the use of High Intensity Focused Ultrasound (HIFU) for the treatment of localized prostate cancer.

More than 27,000 men in the UK are diagnosed with prostate cancer every year, and 10,000 die from the disease.

Hugues de Bantel, CEO of EDAP TMS, said, "We very much welcome these supportive guidelines from NICE. They provide a positive springboard for our continuing efforts to educate both clinicians and patients in the UK about the benefits of HIFU with Ablatherm treatment options. Ablatherm is now officially recognized in the UK."

HIFU with Ablatherm broadens the range of treatment options for patients with localized prostate cancer, offering an alternative therapy for the patients, the company said, calling the therapy "particularly suited to patients who are not candidates for surgery or those for whom radiotherapy treatment has failed. In contrast to surgery, it requires only a short period of hospitalization and has a low complication rate. Unlike radiation, HIFU treatment can also be safely repeated if necessary".

The company said that HIFU with Ablatherm has been used in 7,000 treatments to date worldwide.

In the UK, Stepping Hill Hospital (Stockport) was the first institution in the country to use HIFU with Ablatherm for the treatment of prostate cancer. It has been treating patients for more than a year, as part of a clinical pilot trial, "with very encouraging outcome," EDAP TMS said.

Stephen Brown, MD, consultant urologist at Stepping Hill Hospital, said, "In Europe there is increasing experience with many new centers coming on-line and large numbers of patients being treated. When we started a year ago, we wanted to embark on a UK study to establish whether it is as good as the Europeans are claiming. Results so far are very encouraging. Patients seem very happy with the treatment, but it's still very early days."

EDAP TMS also is developing this technology for the treatment of certain other types of tumors, and it also produces medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy.