A Medical Device Daily

Intraop Medical (Sunnyvale, California) has reported results of a European clinical study in which 651 women and men with locally advanced rectal cancer received intraoperative radiation therapy (IORT) via the company's Mobetron device as part of their treatment.

According to the study results, these patients showed substantial improvement in survival rates and tumor recurrences over those who did not receive IORT.

Intraop Medical said that after standard treatment for advanced rectal cancer – consisting of surgery, chemotherapy and radiation – about 25% of patients are expected to survive five years. Roughly half of these patients have tumor recurrences that require additional surgery, treatment and hospitalization.

In the recent European study, however, patients treated with IORT in addition to standard treatments showed five-year survival rates of 67%, 10-year survival rates of 46%, and five- and 10-year tumor-control rates of 88% and 86%, respectively.

Dr. Harm Rutten, chief of surgery at Catharina Zeikenhuis (Eindhoven, the Netherlands), principal investigator of the study, termed the results “truly exceptional.“

Rutten said that, “as a surgeon who treats many patients with this advanced disease, it is gratifying to have a tool that can help these patients and save their lives.“

The study was conducted by four major European referral centers, all members of the International Society of IORT-Europe. Intraop Medical said it is the largest such study ever reported in medical literature, as well as the largest ever that involved IORT.

Citing what he characterized as “clear evidence of such dramatic tumor control with IORT,“ Dr. Donald Goer, president and CEO of Intraop, said the results “represent a win for the patients, a win for their doctors, and a major win for cost-effective healthcare.“

Goer said the study “strengthens the evidence that IORT and the Mobetron present a major advance in cancer treatments for both women and men.“

The company noted that while colorectal cancer “is widely considered a man's disease, [it] actually affects an equal number of women and men. Detected early, it is highly curable in both genders, with survival rates approaching 90%.“

The Mobetron delivers radiation directly to the tumor bed as part of colorectal cancer surgery. Intraop said: “This is the ideal time to radiologically cleanse the area of any errant cancer cells that might have escaped removal.“

Reimbursement boost for BSD in Germany

BSD Medical (Salt Lake City) said that a reimbursement policy change in Germany now allows the same reimbursement to be charged per treatment as was previously charged per series of treatments for procedures applicable to the company's cancer treatment systems, which deliver precision-focused microwave and RF heat therapy, creating hyperthermia in cancer.

Since patients can be treated multiple times during a treatment series with BSD Medical's systems, the policy change can represent a substantial increase in reimbursement per patient for hospital providers.

The German Institute for Medical Documentation and Information, an agency of the Ministry for Social Affairs, has published the new coding procedure in the latest version of the Operational Coding System (Operations-Schleussel), upon which the German diagnosis-related group's reimbursement system is based.

The German OPS 2006 Extended Operational Code System Catalogue now allows both a separate charge per treatment and provides specialty codes OPS 8-600 for regional deep hyperthermia, OPS 6-601 for party body hyperthermia, including magnetic resonance monitoring, and OPS 8-604 for computerized hyperthermia treatment planning. These codes apply to versions of the BSD-2000 cancer treatment system, including the BSD-2000/3D/MR that uses MRI to monitor temperature levels during cancer treatments.

Dr. Gerhard Sennewald, who distributes BSD Medical's cancer therapy systems in Germany, said the change in reimbursement procedure is “an important step in building further support of hospital-based hyperthermia therapy.“

Twelve BSD-2000 systems are currently installed in German hospitals.

Uroplasty in new agreement with CL Medical

Uroplasty (Minneapolis) said it has signed a new, six-year agreement with CL Medical (Lyon, France) for exclusive distribution of the I-STOP Mid-Urethral Sling product in the U.S. The I-STOP tape is the only monofilament poly-propylene tape designed for application as a sling for the treatment of female stress urinary incontinence.

Uroplasty sells the I-STOP Sling in the UK and the U.S. The new agreement supersedes an earlier agreement sign-ed in September 2004.

The I-STOP Mid-Urethral Sling is a biocompatible, tension-free sling used to treat female stress urinary incontinence resulting from urethral hypermobility, a condition in which the urethra is not properly supported by surrounding tissues. The closed-loop design of the tape provides an atraumatic tape edge; the lengthwise polypropylene strands provide strength, dimensional stability and controlled flexibility; this design resists fragmentation, stretching and deformity during the implant procedure.

The I-STOP sling provides a hammock-like support for the urethra to prevent urine leakage associated with activities such as coughing, laughing, lifting or jumping.

A European multi-center study documented the clinical success of the I-STOP and revealed an 85% patient satisfaction rate among users of the product.

Sam Humphries, Uroplasty president and CEO, said, “We are pleased to further strengthen our long-term, worldwide relationship with CL Medical. This agreement demonstrates our commitment to develop and market a platform of innovative, minimally invasive products for voiding dysfunctions and is a key element in our growth.“

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