A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported that the PROMUS Everolimus-Eluting Coronary Stent System has received CE mark approval.

The European approval makes Boston Sci the only company to offer two distinct approved drug-eluting stent (DES) platforms in the CE regions, it said, and will support market registrations in other regulated countries in Asia, Latin America and Eastern Europe.

The PROMUS Stent is a private-labeled XIENCE V Everolimus Eluting Coronary Stent System manufactured by Abbott (Abbott Park, Illinois) and distributed by Boston Scientific. It will complement Boston Scientific’s market-leading TAXUS paclitaxel DES systems.

It said it expects to launch the PROMUS stent in Europe in 2007.

Paul LaViolette, chief operating officer for Boston Scientific, expressed pride in being able “to offer clinicians the choice of a paclitaxel-eluting stent and an everolimus-eluting stent from the same company, for the first time. We look forward to complementing the proven safety and efficacy of TAXUS with the tremendous potential of PROMUS, further demonstrating the breadth and depth of our DES pipeline ... .”

The SPIRIT Clinical Program is sponsored by Abbott Vascular. PROMUS is not approved for sale in the U.S.

Irish clinic banners IGRT radiotherapy

Recently dedicated was The Whitfield Clinic in Waterford, Ireland, incorporating that area’s first cancer center to offer advanced image-guided radiotherapy (IGRT) treatments. Prior to its arrival, cancer patients in the southeast region of the country were faced with more than two hours traveling time to the nearest radiotherapy centers in Dublin or Cork.

The UPMC Whitfield Cancer Centre houses a Clinac linear accelerator made by Varian (Palo Alto, California), equipped with the country’s first On-Board Imager, enabling advanced image-guided treatments which better target the tumor and protect healthy surrounding tissue. A second linear accelerator will be installed next month.

Dayle Hacking, MD, chief radiation oncologist at the Whitfield Cancer Centre, said, “This region has been crying out for its own dedicated radiotherapy resource, and we now have something that is both local and offers state-of-the-art advanced treatments to improve cancer care.”

The UPMC Whitfield Cancer Centre also will offer intensity-modulated radiotherapy (IMRT) using the Varian equipment and software. The center will enhance patient care by using new software from Varian for planning sophisticated treatments, keeping electronic medical records, processing images and managing clinical processes and operations.

David Scott, UK and Ireland sales manager for Varian, said, “More than half the Irish population has private health insurance and, as the leading supplier to Irish private health centers as well as PPP [public private partnership] projects in Ireland and the UK, Varian is proud to be a part of this project.”

Varian’s On-Board Imager enables clinicians to image and treat on a single machine that rotates around the patient to take X-ray images and deliver treatments from virtually any angle. Mounted on the medical linear accelerator, the On-Board Imager device produces high-resolution images of the tumor and tracks changes in tumor shape, size or position over a multi- week course of treatment.

It also enables clinicians to track and adjust for tumor motion caused by the patient’s breathing. Any adjustments to the patient’s position can be carried out by a radiation therapist entirely from outside the treatment room, allowing for faster, automated image-guided radiotherapy.

There are more than 5,800 radiotherapy centers worldwide, and Varian reports that it equips 60% of them with its integrated and automated radiotherapy systems. It says it has installed more than 250 On-Board Imager systems to date around the world.

Varian bills itself as the world’s leading manufacturer of medical technology for treating cancer and other medical conditions with radiotherapy, brachytherapy, and radiosurgery.

‘Live’ tissue welding reported on

CSMG Technologies (Corpus Christi, Texas), a technology management company focused on commercializing human live tissue bonding devices and also renewable energy landfill gas production, reported that its Live Tissue Connect Technology subsidiary received a positive response from the Bulgarian Medical Academy of Science . In the three day symposium Oct. 10–12, the Live Tissue Connect technology was presented by CSMG Technologies and Ukraine researchers in a symposium entitled “Welding of Live Tissues,” sponsored by the Bulgaria Academy of Sciences.

The LTC tissue bonding/welding device is a platform technology that bonds and reconnects living soft biological tissue through fusion without the use of foreign matters or conventional wound closing devices such as sutures, staples, sealant or glues.

The presentation included Live Tissue Connect’s Ukraine surgeon’s presentations at the symposium as well as a live demonstration at the Military Medical Academy .

Donald Robbins, president and CEO of CSMG, said, “We are looking forward to working with Bulgaria, a country of approximately 8 million people, as our next commercial market where we have already received indications of interest for device purchases.”

The company reported that surgeons at 27 Ukraine hospitals and clinics are using the technology in clinical trials and have completed more than 6,000 human surgeries using more than 80 types of open and laparoscopic procedures, demonstrating the technology is universal in its ability to repair soft biological tissue.

These surgeries included lung, neuro-surgery, nasal septum, intestine, stomach, skin, gall bladder, liver, spleen, blood vessels, nerves, alba linea, uterus, bladder, gynecological, fallopian tube, ovary and testicles and dura-matter. Cosmetic surgeries conducted with this technology include breast reduction, breast implants, mastopexy and abdominal plasty. The procedure involves little or no scarring, while restoring the normal function of the body organ or tissue.

The technology was invented and developed at the E.O. Paton Institute of Electric Welding, National Academy of Sciences Kiev headed by Professor B.E. Paton. Australia patents for the technology have been issued, a patent in the European Union has been approved, and additional U.S. and foreign patents are pending.