A Medical Device Daily

Pall (East Hills, New York) said that Health Canada granted it clearance to market the Acrodose PL System. The new system gives blood centers the ability to pool and store whole blood-derived platelets and conduct a single bacterial detection test that enhances patient safety and increases platelet availability.

The resulting Acrodose Platelet provides hospitals with a transfusion-ready product that is safer than currently available whole blood-derived platelets, Pall said. It also reduces the cost burden to hospitals by eliminating the need for additional processing and testing.

“The Acrodose PL System sets a new paradigm in transfusion therapy as it addresses many of the limitations the blood industry faces including platelet availability, compromised safety and high cost,” said Allan Ross, president of Pall Medical. “Blood centers and hospitals . . . will now be able to cost-effectively increase the availability of bacterially tested, leukoreduced and pooled whole blood derived platelets.”

Pall said adequate availability of safe platelets is a “fundamental blood transfusion challenge. There is a disparity in the level of safety that currently exists between platelets that are derived from a one- to two hour-procedure called apheresis (single donor) or from standard whole blood collections.”

The company said the Acrodose PL System eliminates the safety and availability disparity by providing a cost-effective way to test all types of platelets for bacterial contamination using a highly sensitive, culture-based test.

Apheresis platelets are generally tested for bacterial contamination using a highly sensitive culture-detection method. With the Acrodose PL System, whole blood-derived platelets can be pooled and tested for bacteria as a single testing sample using a highly sensitive detection method. This increases the safety of transfused platelets on a cost-effective basis, Pall said, ensuring that this valuable blood resource is more readily available.

“There has been a very positive reception to and adoption of the Acrodose PL System in both large and small blood centers across the U.S,” Ross said. “Patients and their providers throughout Canada will now be able to reap these same platelet safety and availability benefits.”

PreMed tops trial enrollment target

Predictive medicine company PreMD (Toronto) said that it has exceeded its enrollment target in the 600-subject PASA (Predictor of Advanced Subclinical Atherosclerosis) study with 650 patients. PASA is examining the relationship between skin tissue cholesterol (sterol) and carotid intima media thickness (CIMT), which refers to the thickness of the first two inner layers of the carotid artery wall. CIMT is an established predictor of heart attack and stroke.

The PASA study is aimed at supporting broader regulatory clearance for the PREVU(x) Point of Care Skin Sterol Test as well as PREVU(x) LT Skin Sterol Test as a tool to identify asymptomatic patients at risk of a primary event, such as heart attack or stroke.

Dr. Brent Norton, president and CEO, said, “We will be analyzing the data in the coming months and expect to be in a position to make various regulatory submissions to the FDA and in Canada and Europe before the end of the year.”

PREVU(x) noninvasively measures the amount of cholesterol that has accumulated in the skin tissues, as opposed to blood. No fasting or other patient preparation is required for the test.

Clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels in the skin are correlated with higher incidence of coronary artery disease.

PREVU(x) POC is cleared for sale in Canada, the U.S. and Europe.

PreMD's cardiovascular products, which are branded as PREVU(x) Skin Sterol Test, are licensed worldwide to McNeil Consumer Healthcare. The company's cancer tests include ColorectAlert, LungAlert and a breast cancer test.

The company's research and product development facility is at McMaster University (Hamilton, Ontario).

'Next-generation' vision assessment

Nidek (Gamagori, Japan), a manufacturer of optical and eye care diagnostic instrumentation, reported the introduction of its OPD-Scan II ARK-10000, which it characterized as launching “the next generation in . . . quality of vision assessment.”

The OPD-Scan II combines corneal topography, wavefront, autorefraction, keratometry and pupillometry into one system.

The system uses the principles of skiascopic phase difference to assesse and determine refractive error map measurements. Nidek said the corneal topography function uses Placido disc technology to analyze thousands of data points to plot corneal contour, shape and refractive power.

The company said that by offering a variety of informative data maps, the OPD-Scan II provides detailed information on the total refractive error, wavefront, corneal shape, internal aberrations and overall visual quality of the eye, generating accurate and reliable information for optical diagnostics.

A new feature added to the OPD-Scan II ARK-10000 is the Corneal Navigator, which uses various corneal parameters from topography, to automatically determine corneal features and reveal possible corneal conditions on an instantaneous basis.

Nigerian order for HIV rapid tests

Chembio Diagnostics (Medford, New York) said it has received an order from the procurement agent on behalf of the U.S. Centers for Disease Control and Prevention office in Nigeria for 200,000 HIV 1/2 STAT-PAK rapid tests to be used for voluntary counseling and testing programs in that country.

The company said it plans to ship most of this order this quarter. The President's Emergency Plan for Aids Relief (PEPFAR) is funding the purchase. PEPFAR is a five-year, $15 billion global initiative to combat the HIV/AIDS epidemic.

The Nigerian Ministry of Health has designated Chembio's HIV 1/2 STAT-PAK as a screening test in four out of the eight testing protocols that comprise that country's Interim National Testing Algorithm. Nigeria is initially implementing a parallel testing algorithm, and as such uses two screening tests from different manufacturers on each patient tested.

Avi Pelossof, vice president of sales, marketing and business development at Chembio, said, “This is the first significant order from Nigeria since our tests were selected [there]. We believe Nigeria's demand for HIV rapid tests will increase significantly in order to meet treatment goals under PEPFAR.”

About 3.6 million Nigerians are estimated to be HIV-infected. Only a small percentage of those estimated to be HIV-infected are aware of their status, and only 28,500 are currently receiving anti-retroviral treatment, according to a recent report to Congress by PEPFAR.

South Korean distributor for Sontra

Sontra Medical (Franklin, Massachusetts) said it has signed a distribution agreement with JOYMG (Seoul, South Korea), a medical device distribution company, to market and sell Sontra's SonoPrep Skin Permeation System in that country.

The exclusive agreement is subject to JOYMG obtaining approval by the Korean regulatory body, which JOYMG said it expects to receive within 90 days.

Sontra said training of JOYMG's sales and marketing organizations will begin during the next month and plans are being made for introduction of the SonoPrep System at medical conferences in Asia.

Barry Marston, vice president of sales and marketing at Sontra, said, “The recent regulatory approvals for the second-generation SonoPrep System have opened the doors to the international marketplace. Now that we have ISO 14385 certification and CE marking, we hope that this arrangement is the first of many global opportunities for Sontra and its SonoPrep System.”

Sontra's SonoPrep technology is being developed for several market opportunities, including continuous glucose monitoring and the transdermal delivery of large-molecule drugs and vaccines. The company is currently marketing the SonoPrep device and procedure tray for use with topical lidocaine to achieve rapid skin anesthesia.

Rockwell's SFP gets Hong Kong patent

Rockwell Medical Technologies (Wixom, Michigan), a manufacturer of concentrates and specialty pharmaceuticals focused on the end-stage renal disease (ESRD) market, reported that the Hong Kong Patent and Trademark Office has issued a patent for Rockwell's SFP product.

The patent covers the “Method and Pharmaceutical Composition for Iron Delivery administered via Dialysate in Hemodialysis and Peritoneal Dialysis Patients.”

The SFP product is a soluble form of iron called ferric pyrophosphate. It is designed to provide iron maintenance therapy in ESRD patients by delivering iron via dialysate during a dialysis treatment.

Rockwell has licensed the exclusive rights to the SFP patent and is in the process of seeking FDA approval to market the product.

Compared to intravenous (IV) iron administration, early clinical study results have shown that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs.

Rockwell estimates that the U.S. market for IV iron delivery is as much as $450 million annually, while the global market potential is about $750 million annually.

Robert Chioini, chairman, CEO and president of Rockwell, said, “We believe the markets along the Pacific Rim hold tremendous potential for SFP. This patent approval in Hong Kong is a significant step toward commercial realization of SFP in an important market.”