A Medical Device Daily

TomoTherapy (Madison, Wisconsin) said that Saudi Arabia's leading cancer center, King Faisal Specialist Hospital & Research Center (KFSH&RC; Riyadh), will become the region's first to treat patients with the company's Hi Art treatment system, a next-generation radiation therapy solution designed to improve the precision of cancer care.

KFSH&RC commemorated the system installation in a ceremony held during a scientific meeting at the hospital earlier this month.

The meeting, titled "Innovative Approaches in Radiotherapy: Beyond Tomorrow," attracted radiation oncology professionals from throughout Saudi Arabia and featured a roster of speakers, including TomoTherapy co-founder/ chairman Thomas (Rock) Mackie, PhD.

Mackie said, "TomoTherapy is . . . pleased to partner with this world-renowned center as it implements the only solution designed to deliver on the promises of image-guided, intensity-modulated radiation therapy [IG-IMRT]."

The company said the Hi Art system is unique among radiation therapy devices in its computed tomography (CT) scanner-based design, which allows clinicians to acquire a true CT image of the patient immediately before daily treatment to help ensure accuracy.

"Then, using the same equipment as used in imaging, the treatment team can deliver highly-precise radiation in a continuous, 360-degree [helical] pattern," TomoTherapy said.

"We look forward to employing TomoTherapy treatment technology to benefit our patients in terms of minimization of dose to normal tissue and improvement of side-effect related outcomes," said Mohammad Al-Shabanah, MD, section head of radiation oncology at the 894-bed Saudi hospital. "One area of interest for us is the use of total marrow irradiation to support our large bone marrow transplant program."

Dr. Belal Moftah, chairman of the department of biomedical physics at KFSH&RC, said, "We are very excited at King Faisal Specialist Hospital & Research Center to open our TomoTherapy unit, which is the first in the Middle East. We plan on maximizing the advantages of integrated CT imaging and highly-modulated beam delivery that TomoTherapy provides."

TomoTherapy' distribution partner in Saudi Arabia is Attieh Medico.

Trial eyes quantitative MRI

VirtualScopics (Rochester, New York), a provider of quantitative imaging for clinical trials, said that BioSyntech (Laval, Quebec) has reached its enrollment goal in the Canadian-European pivotal clinical trial for its cartilage repair device, BST-CarGel, and now will focus on quantitative measures to determine enhanced efficacy compared to the microfracture surgical technique.

Historically, clinical trials for cartilage-related therapies have used pain as the primary endpoint. In the BST-CarGel study, however, VirtualScopics is providing blinded data analysis of quantitative MRI, which will allow BioSyntech to demonstrate BST-CarGel's potential for affecting the quantity and quality of the repaired cartilage as their primary endpoint.

"We are very pleased to be working with BioSyntech on this unique Canadian-European pivotal trial," said Jeff Markin, VirtualScopics president/CEO. "The quantitative nature of these endpoints offers the opportunity to design cartilage repair trials that may be smaller or shorter in comparison to conventional designs which use more qualitative or subjective endpoints. We look forward to providing BioSyntech the critical information they need to demonstrate the effectiveness of their product."

Dr. Matthew Shive, chief scientific officer at BioSyntech, said, "VirtualScopics' experience in incorporating standardized, yet advanced, imaging into international, multi-center clinical trials has allowed us to conduct what we believe to be the first trial of its kind in cartilage repair. Strategically, their expertise permitted us to focus on the key parameters of repair which are most prominent following treatment with BST-CarGel."

VirtualScopics is a provider of imaging solutions to accelerate drug and medical device development. It has developed what it terms "a robust software platform for analysis and modeling of both structural and functional medical images."

Thai distributor for Cardima

Cardima (Fremont, California), manufacturer of the Cardima Surgical Ablation System and the Revelation line of therapeutic electrophysiology (EP) catheters, has appointed DKSH Healthcare (Zurich, Switzerland) as its distributor for Thailand.

DKSH will provide Cardima with an integrated solution, including regulatory, logistics, marketing, sales, physician training, distribution and after-sales services. Cardima's EP products and Surgical Ablation System already have received product registration approval in Thailand.

Cardima also is partnering with MEDS Global, the Thai Ministry of Health, Ramathibodi Hospital and Mahidol University Medical School to develop a Center of Excellence in Bangkok for the treatment of AF.

Cardima said it has completed its second phase of cardiothoracic surgeon training in Thailand on the use of the Cardima Surgical Ablation System in a closed-chest setting. This minimally invasive procedure uses the Cardima Surgical Ablation System via a two port unilateral approach.

The Thai Center of Excellence program will train physicians in public and private hospitals. These physicians are expected to treat Thai, as well as international "tourist medicine" ablation patients.

Cardima CEO Robert Cheney said, "DKSH has a long history and extensive experience marketing medical products in the Asia Pacific region, making it an ideal partner for Cardima in Thailand."

China Medical's SPR advances

China Medical Technologies (Beijing, China), a company that manufactures advanced in vitro diagnostic products, said it has received a quality testing certificate for its SPR-based Analysis System from one of the State Food and Drug Administration Quality Supervision and Testing Centers.

"Receipt of the certificate marks an important milestone during the SFDA approval process for our SPR System," said Xiaodong Wu, chairman/CEO. "We will continue to work on the approval process, which includes the commencement of 120 clinical trial samples by three SFDA-authorized Tier-1 hospitals and subsequent administrative procedures by the SFDA before its approval."

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