A Medical Device Daily

RaySearch Laboratories (Stockholm) and Nucletron (Veenendaal, the Netherlands) reported initiating a new collaborative effort for the treatment planning of proton radiation therapy of cancer.

The companies entered into a long-term development and license agreement that will result in a system for treatment planning and optimization of radiation therapy with protons. The new system, which is being built by RaySearch, will be integrated in Nucletron’s treatment planning system Oncentra MasterPlan.

”We are now moving into the field of treatment planning for proton therapy, a step that is in line with RaySearch’s business idea to provide innovative software for more effective radiation therapy. This advanced application fits well with our expertise profile and will contribute to a broadening of the ORBIT platform with ground-breaking functionality,” says Johan president/CEO of RaySearch.

L f said, “Nucletron is contributing the background knowledge within the physics of protons, which is extremely valuable. The demand for new treatment planning products for protons is increasing rapidly. Among other indications, this was confirmed at the PTCOG [particle therapy co-operative group] proton conference ... in the U.S. in October in which RaySearch participated and demonstrated a prototype. Several new clinics for proton therapy are being planned and RaySearch where Nucletron will participate in the tender process.”

He said that proton radiation therapy has potentially even better clinical properties than intensity modulated radiation therapy (IMRT), based on photon radiation. Conventional radiation therapy is normally delivered with photons, which are generated by accelerating electrons. Protons are considerably heavier particles than electrons and therefore large installations are needed for acceleration of theses particles. Proton therapy requires extremely expensive equipment and highly sophisticated software.

Nucletron develops products for cancer treatment, with expertise in brachytherapy, treatment planning systems, information processing and simulation. The company has more than 20 offices worldwide.

RaySearch develops software for radiation therapy of cancer designed to optimize radiation therapy with the aim of adapting the radiation dose to the contour of the tumor, which then allows high doses to be delivered to the tumor while minimizing the dose to surrounding healthy tissue. RaySearch is a year 2000 spin-off from Karolinska Institutet.

Angiotech seeks CE-marking for wrap

Angiotech Pharmaceuticals (Vancouver, British Columbia), a specialty medical device and pharmaceutical company, reported that it has submitted an application for a CE Mark for its Vascular Wrap paclitaxel-eluting mesh/ePTFE vascular graft combination product on the strength of the results from its European first-in-man study.

“This filing is an important milestone for Angiotech,” said William Hunter, MD, president/CEO of Angiotech. “With the acquisition of the vascular graft product line from Edwards Lifesciences [Irvine, California] last year, as well as the acquisition this year of American Medical Instruments, we believe we are well positioned to capitalize on and economically benefit from this potentially category-defining product. “We believe the market potential for our Vascular Wrap product could be significant. With the results from the two-year European study and our upcoming trials in AV Access in the UK and US, we believe that we have the potential to build a significant vascular franchise.”

The two-year trial produced evidence that treatment with the Vascular Wrap reduced the overall incidence of leg amputation and prolonged limb retention time in patients suffering from late stage peripheral arterial disease who underwent bypass surgery. For the patients that required an amputation during the study period, the mean interval to amputation for patients treated with the Vascular Wrap was 156 days — more than double the mean interval to amputation for the control, which was 76 days.

At the same time, the Vascular Wrap appeared to be well tolerated, with no adverse events being considered related to the use of the product.

Angiotech’s Vascular Wrap paclitaxel-eluting mesh/ePTFE graft combination product technology is being developed for use in hemodialysis access and peripheral arterial bypass surgery. It is a combination product consisting of both the ePTFE graft and the Vascular Wrap paclitaxel-eluting mesh. The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech’s paclitaxel technology in a biomaterial with the goal of mitigating scar formation caused by abnormal blood flow thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.

Misonix reports a ‘first’ in Hungary

Misonix (Farmingdale, New York), a developer of ultrasonic medical technology for the treatment of cancer and other chronic conditions, reported that it is the first company to participate in a High Intensity Focused Ultrasound (HIFU) procedure in Hungary using the Sonablate 500 for the treatment of prostate cancer.

The SOTE Urological Clinic at the University Hospital of Budapest has been the first to perform HIFU.

“We are excited to be the first to introduce minimally invasive, visually directed HIFU to the prostate cancer patients of Hungary. We are encouraged with the reported low morbidity and high curative rates throughout Europe, and hope to mirror those results with our patients,” said Imre Romics, a professor at the hospital.

“We are pleased to see the continued acceptance of the Visually Directed HIFU as the leader in the successful treatment of prostate cancer,” said Michael McManus Jr., president/CEO of Misonix.

Misonix manufactures medical, scientific, and industrial ultrasonic equipment, laboratory safety equipment, and air pollution control products. Misonix’s ultrasonic platform is the basis for several innovative medical technologies. Misonix has a minority equity position in Focus Surgery, which uses HIFU technology to destroy deep-seated cancerous tissues without affecting surrounding healthy tissue. Addressing a combined market estimated to be in excess of $3 billion annually, Misonix’s ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications.