A Medical Device Daily

Covidien (North Haven, Connecticut) said its surgical devices business unit has introduced the VascuSeal vascular sealant system throughout Europe and in select Middle East markets.

The VascuSeal sealant technology is a synthetic, absorbable hydrogel delivered by a dual-syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. Covidien said the VascuSeal sealant "polymerizes within seconds when sprayed on the suture line and is blue in color, which provides the vascular surgeon visualization of coverage and thickness of the material upon application."

The company said VascuSeal "offers surgeons a unique advanced hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period."

VascuSeal, which is CE-marked, is intended for use as a surgical sealant during arterial and venous reconstructions to seal suture lines. Unlike hemostatic agents, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully.

Covidien said the VascuSeal system "offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding."

Postoperatively, VascuSeal sealant continues to seal the suture line as healing progresses under the gel. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.

CE mark for BD's VanR assay

BD Diagnostics, a unit of BD (Becton, Dickinson and Co.; Franklin Hills, New Jersey), reported the CE-marking of the BD GeneOhm VanR assay for the rapid detection of vanA and vanB genes, which are associated with vancomycin-resistant Enterococci (VRE).

BD said it would immediately begin commercializing the new assay throughout Europe.

The company said that VRE-associated infections have a high attributable mortality rate and are associated with excess costs and length of stay. According to BD, VRE prevalence in healthcare facilities has increased steadily since it was first reported in 1987 and now accounts for about 30% of enterococcal infections in intensive care unit patients in the U.S. In Europe, the majority of countries report vancomycin-resistance rates ranging from 25% to 50% of enterococcal isolates.

The BD GeneOhm VanR assay is a qualitative in vitro polymerase chain reaction test for the detection of vancomycin-resistant genes directly from perianal and rectal swabs.

The first CE-marked molecular assay to directly test clinical specimens, the test allows hospitals and reference laboratories to identify patients colonized with the resistant organisms associated with VRE in as little as two hours. Conventional culture-based microbiology algorithms require three to four days to produce definitive test results.

BD said the new test will help enable earlier implementation of infection control measures to prevent VRE transmission and infection, leading to decreased length of stay and reduced healthcare costs.

EU approves start of Cytori study

Cytori (San Diego) has received approval to begin its European stem and regenerative cell-enhanced breast reconstruction study in breast cancer patients who have undergone partial mastectomy. The post-market study is designated as RESTORE II.

The primary goal is to obtain European reimbursement for cell-enhanced reconstruction using the Celution 800 System by measuring key quality of life improvements in breast cancer patients desiring reconstruction. Up to 70 women will be enrolled at six clinical centers in the UK, Italy, Spain and France.

Primary endpoints will be patient and physician satisfaction with functional and cosmetic outcomes at six and 12 months after surgery. Cytori's goal is to complete enrollment before the end of March 2009.

The company said there currently is no generally accepted reconstructive technique for partial mastectomy patients, "despite the fact that breast-conserving therapy is standard practice in the treatment of women with breast cancer worldwide."

In the RESTORE II study, tissue loss resulting from partial mastectomy will be reconstructed with the patients' own fat tissue, which will be enhanced with their adipose-derived stem and regenerative cells. That procedure is referred to as cell-enhanced reconstruction.

The cells in the study will be made available at the time of surgery using Cytori's Celution 800 System.

"RESTORE II is important for advancing reconstructive options for women with breast cancer," said Emmanuel Delay, PhD, the study's principal investigator and chief of plastic and reconstructive surgery at the Leon B rard Cancer Center (Lyon, France). "A successful study should broaden availability of this therapy to partial mastectomy patients in Europe."

"Unfortunately fewer options are available to women desperate for reconstructive surgery following partial mastectomy due to the effects of the adjuvant radiotherapy," said Eva Weiler-Mithoff, surgeon at the Glasgow Royal Infirmary (Glasgow, Scotland) and lead investigator for the UK study site. "Adipose tissue enriched with stem and regenerative cells represents a new approach that we believe allows for predictable graft retention."

Secondary endpoints include six- and 12-month assessments of breast volume and shape via MRI and improvement in skin pigmentation. The study will evaluate patients who have undergone their last breast treatment at least 12 months prior and are recurrence-free.