A Medical Device Daily

NMT Medical (Boston) said its BioSTAR device, which incorporates a bioresorbable collagen scaffold used to treat patent foramen ovale (PFO), has received regulatory approval in Canada and Europe.

PFO is a common defect between the right and left atrium of the heart — essentially a hole in the heart that is usually asymptomatic. However, PFO may allow unfiltered blood and micro-emboli to pass directly into the arterial circulation and cause cerebral events, such as a stroke.

NMT said the BioSTAR product, which features the FortaFlex technology created by Organogenesis (Canton, Massachusetts), is designed to close PFO using the patient’s natural healing response.

The company said PFO has been “directly linked to incidence of strokes, but recent studies suggest that there may even be a link between PFO and the development of certain migraines ... which affect [about] 28 million people in the U.S. alone.”

NMT described FortaFlex as “an innovative, bioresorbable collagen scaffold that consists of highly purified and very strong sheets of collagen. FortaFlex is a modular platform technology that can be custom bioengineered to meet the needs of a variety of surgical applications using a unique lamination and crosslinking process.”

The company said its BioSTAR device incorporates the FortaFlex scaffold to function like a pair of small umbrellas. “When the BioSTAR device is deployed at the PFO, an umbrella of FortaFlex sits on both the right and left atrium of the heart, effectively closing the hole between the heart chambers.” Between 90% and 95% of the implant is absorbed over time and replaced with the patient’s own tissue, resulting in micro-emboli and unfiltered blood being blocked from passing into the arterial circulation and thus averting a potential stroke.

BioSTAR and the FortaFlex technology were used to close PFO in the UK-based, multi-center BioSTAR Evaluation Study (BEST) clinical trial. NMT said that at six months, 96% of the patients who received the device achieved complete PFO closure and no adverse events were reported.

Organogenesis CEO Geoff MacKay said, “What’s exciting is that this is reflective of the growing trend for biological materials like collagen to replace synthetic materials in many surgical procedures. Collagen is 25% of our total body protein; it is contained in skin, fascia, bones and teeth. Therefore, using collagen to repair and support parts of the human body makes perfect sense.”

Siemens ELF test now available

Siemens Medical Solutions Diagnostics (Tarrytown, New York) reported the availability in Europe of its Enhanced Liver Fibrosis (ELF) test, which it said is “the first CE-marked, standardized non-invasive blood test for assessing the status of liver fibrosis.”

The Siemens ELF test was first validated in an international multi-center study and is now available through iQur (Southampton, UK) as a testing service for patient management.

The company noted that chronic liver disease — resulting from alcoholic liver disease, fatty liver or viral hepatitis — is increasingly recognized as a major cause of morbidity and mortality. “Standard liver function tests do not accurately reflect the true extent of fibrotic damage or, in many cases, may detect it too late,” Siemens said.

Liver biopsies are routinely performed to assess liver damage, or fibrosis, as well as to try to monitor the effectiveness of drugs in tackling the disease. “Performing a liver biopsy is a hazardous, expensive and painful experience for the patient and does not always provide accurate results because of difficulties in sampling and interpretation,” the company said. “Fibrosis is not evenly distributed throughout the liver and because such a small amount of biological material is sampled, 55% of 15 mm biopsies may be misclassified. Larger biopsies can be performed, but even with 25 mm sections, 45% will be erroneous.”

Siemens Diagnostics said that because ELF uses a blood sample rather than a biopsy, it can be used routinely for the same patient and helps monitor progression of fibrosis in the patient’s liver.

“The benefit of the Siemens ELF test is that it can be used repeatedly, with minimal patient discomfort, to monitor disease progression and response to therapy,” said David Okrongly, senior vice president, Molecular Business Unit, Siemens Medical Solutions Diagnostics. “It’s the first standardized laboratory method for assessment of liver fibrosis which requires only a simple sample of blood. We are delighted that iQur now offers this ELF test as an incremental service for physicians managing patients with chronic liver disease.”

The ELF test combines three serum biomarkers – hyalurinic acid, procollagen III amino terminal peptide and tissue inhibitor of metalloproteinase 1 — that have been shown to correlate to the level of liver fibrosis assessed by liver biopsy.

An algorithm measures each of these markers by immunoassay, to create an ELF score. Sampling for the ELF test can be performed in a physician’s office or health center, avoiding the need for a patient to travel to a hospital.

Croarkin named CFO of Alcon

Alcon (Huenenberg, Switzerland) said that Richard Croarkin will be named senior VP and CFO of the company effective Aug. 1.

Croarkin comes to Alcon from Nestlé SA , where he was executive VP finance and CFO of Nestlé Waters North America. He joined Nestlé Waters North America in 1994 and has overseen the finances of a business unit that has grown to $4.4 billion in sales.

Before joining Nestlé, Croarkin worked for Pepsico for 11 years, where he served in a number of senior financial positions around the world, including as CFO of Pepsi Latin America and Pepsi Canada.

Alcon terms itself “the world’s leading eye care company,” with 2006 sales of about $4.9 billion. Its majority shareholder is Nestlé, the world’s largest food company.