A Medical Device Daily

Sanuwave (Alpharetta, Georgia), a developer of extracorporeal shock wave technology (ESWT) and pulsed acoustic cellular expression (PACE) technology, said its dermaPACE device has received CE mark approval to treat acute and chronic defects of the skin and subcutaneous soft tissue, such as in the treatment of pressure ulcers, diabetic foot ulcers, burns, and traumatic and surgical wounds.

The company estimates about 2 million chronic and/or complex wounds occurring in the European Community that could benefit from dermaPACE.

An abstract presented during the Wound Care Congress in Colorado Springs, Colorado, last October documented the treatment of nine diabetic patients with chronic leg ulcers of greater than six months duration treated with dermaPACE. The patients received a series of four PACE treatments over the course of two weeks and were followed for three months. Results of the pilot study showed that all wounds improved using the dermaPACE, and 75% of the wounds achieved more than 92% closure during the study period.

Florian Kamelger, MD, one of the study investigators, said, "Our preliminary results are extremely encouraging for this difficult patient population. The wounds that were treated in the study represent the most difficult wounds to heal, and we feel that this technology has great potential for a variety of acute and chronic wound conditions."

Christopher Cashman, president/CEO of Sunuwave, said, "This regulatory approval represents a significant milestone accomplishment for Sanuwave. Hard-to-heal wounds are a global economic burden on healthcare systems, insurers and individual financial accounts, not to mention the emotional drain on each person affected. Sanuwave can offer a new emerging care option for these patients that helps alleviate the mental, physical, and financial stresses associated with these skin maladies."

The biological working mechanism of dermaPACE is based on the application of high-energy pulsed acoustic waves to the affected area. PACE produces microscopic stresses at a cellular level signaling for the cellular release of specific proteins (cellular expression) including angiogenic growth factors that have been clinically shown to result in new supportive blood vessel growth, also known as neovascularization.

These acoustic wave-induced stresses also lead to an inflammatory response that contributes to an increase in microcirculation, according to the company. The combined effect has been shown to have a positive outcome on chronic wound conditions.

In addition to its headquarters in Alpharetta, Sanuwave has international offices in Lengwil, Switzerland, and Tokyo. Its OssaTron is the standard of care for electro-hydraulic ESWT, and is approved for use by the FDA for chronic plantar fasciitis and chronic lateral epicondylitis, more commonly known as heel pain and tennis elbow.

Vascular Wrap study begins

Angiotech Pharmaceuticals (Vancouver, British Columbia) reported the initiation of a European study evaluating the safety and efficacy of its Vascular Wrap paclitaxel-eluting mesh after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular (AV) access.

"Patients with end-stage renal disease today face the high probability that their AV graft will fail within the first year of use," said Dr. Eric Chemla, coordinating investigator of the study based at St. George's Healthcare NHS Trust (London).

The company said the Vascular Wrap product has the potential to save dialysis patients from the further health and financial burdens of repeated surgeries and additional hospitalizations.

William Hunter, MD, president/CEO of Angiotech, said, "We believe that the Vascular Wrap product will be a key catalyst for building out an Angiotech-branded, vascular franchise. We expect that the results from this European study and the ongoing U.S. pivotal trial will form the groundwork for expanding the potential indications for the Vascular Wrap technology."

The European study will involve some 198 patients at 20 centers in Europe. The first patient was enrolled by Dr. Ali Bakran at the Royal Liverpool University Hospital (Liverpool, UK). Within one year following vascular access surgery, the patency of the Vascular Wrap combined with an ePTFE vascular graft will be compared to a control group of patients who receive the standard of care, an ePTFE vascular graft alone.

In March, Angiotech launched a similar pivotal trial in the U.S. (Medical Device Daily; March 20, 2007), also designed to evaluate the safety and efficacy of the Vascular Wrap after surgical implantation with an ePTFE vascular graft in the upper extremity for AV access.

Last November, Angiotech reported results from its European first-in-man study examining the safety and clinical performance of the Vascular Wrap when used to treat patients suffering from advanced peripheral arterial disease (PAD) in their lower limbs (MDD; Nov. 10, 2006). Based on the strength of this two-year data, Angiotech submitted an application for a CE mark for the Vascular Wrap paclitaxel-eluting mesh/ePTFE vascular graft combination product for this indication.

European patent to Ciphergen

Ciphergen Biosystems (Fremont, California) said the European Patent Office has issued EU Patent No. 1 354 203, titled "Biomarkers of Transitional Cell Carcinoma of the Bladder," for aiding in bladder cancer diagnosis when used in conjunction with the current standard of care – cystoscopy, a diagnostic procedure that uses a scope to view the bladder.

The patent describes using mass spectrometry to detect certain protein biomarkers that are present in patients with bladder cancer vs. patients who do not have bladder cancer. These discoveries were made under a collaborative agreement between Ciphergen and Eastern Virginia Medical School (Norfalk). Ciphergen retains exclusive rights to the discoveries for diagnostic development.

"The issuance of this patent is another example of [our] growing intellectual property portfolio and the productivity of our collaborations, which continue to support the expansion of our high-value diagnostic development programs," said Ciphergen CEO Gail Page. "In collaboration with our partners, we continue to generate promising biomarker data that may be useful for aiding physicians in cancer diagnosis, disease monitoring, or prediction of recurrence."