A Medical Device Daily

PLC Systems (Franklin, Massachusetts), a company focused on cardiac and vascular device-based technologies, said it has entered into a three-year exclusive agreement with Artech (Cavezzo, Italy) for distribution of the RenalGuard System in that country.

RenalGuard is an automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

PLC said Artech is "one of Italy's leading distributors of interventional cardiology-related medical devices, doing business with most of Italy's major interventional cardiology centers."

Artech will target early adopters who recognize the benefits of utilizing the unique fluid-balancing capabilities of RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of contrast-induced nephropathy (CIN).

PLC Systems said CIN is "a major and growing problem," due to the increasing number of older patients, diabetics and patients with pre-existing renal failure all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. It said CIN is the third-most-common cause of in-hospital acute renal failure.

As part of this new agreement, Artech placed an initial stocking order for EUR 90,000 (about $144,000) for RenalGuard Consoles and single-use sets to support the initial sales launch of RenalGuard at selected major cardiology centers throughout Italy.

PLC President/CEO Mark Tauscher said, "Our initial launch in Italy will be supported by the previously announced planned clinical trial at the Centro Cardiologico Monzino (CCM-University of Milan) in Milan. This study, which will be led by Drs. Antonio Bartorelli and Giancarlo Marenzi, two experts in the prevention of CIN, is expected to receive final approval by the ethics committee at CCM this spring and lead to increased market visibility for our RenalGuard System."

PLC received CE-mark certification for the RenalGuard System in late-December 2007, and concluded its pilot safety trial in the U.S. late in the year as well. The company has received conditional approval from the FDA to begin a U.S. pivotal trial to study the effectiveness of RenalGuard therapy in the prevention of CIN.

First sales in China for Biosphere Medical

BioSphere Medical (Rockland, Massachusetts), a company that has pioneered the use of bioengineered microspheres to treat various medical conditions by a minimally invasive, image-guided medical procedure called embolotherapy, reported having shipped its first order of Embosphere Microspheres to China.

In January, the Medical Device Department of the State Food and Drug Administration (SFDA) approved Embosphere Microspheres for clinical use for vascular embolizations, arteriovenous malformations, hypervascularized tumors and symptomatic uterine fibroids.

President/CEO Richard Faleschini said, "We ... have commenced shipments into China, as scheduled, and view this as a key milestone for BioSphere. We believe that among the estimated 150 million to 200 million Chinese with health coverage are a large number of patients who have been and are being treated for benign and malignant hypervascularized tumors, such as uterine fibroids and hepatocellular carcinoma."

BioSphere Medical is a developer of minimally invasive diagnostic and therapeutic applications based on its bioengineered microsphere technology. The company's principal focus at present is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization.

Chinese okay Microcyn technology

In other China news, Oculus Innovative Sciences (Petaluma, California) said the SFDA has approved Microcyn technology for use in that country. The agency approved Microcyn technology for treatment of various acute and chronic wounds including ulcers, cuts, contusions and burns.

Oculus said the approval allows its Chinese partner, China Bao Tai, to market Microcyn as a technology that provides a moist environment for wounds and accelerates wound-healing through the reduction of microorganisms in wounds.

This approval follows the completion and submission of two randomized, controlled Chinese clinical trials of Microcyn in December 2007 a burn wound study with 162 patients and a chronic wound treatment study with 35 patients.

Oculus entered into an agreement with China Bao Tai in 2007 for the distribution of Microcyn-based products in China.

"We believe that the Chinese medical community will enthusiastically embrace an anti-infective technology that is proven both safe and effective in treating infection in chronic wounds and burns," said Yan Bing, president of Sinopharm, China Bao Tai's sub-distributor for hospitals and pharmacies. "We read the SFDA's rapid approval as a signal that the marketplace is eager for an anti-infective that works as promised and doesn't appear to promote bacterial resistance, as is the case for many of today's antibiotics."

Molecular imaging production facility opened

Siemens Healthcare (Hoffman Estates, Illinois) reported the establishment of its first molecular imaging biomarker production facility in Chennai, India. The company said the new facility will enable healthcare providers in and around Chennai to access the positron emission tomography-computed tomography (PET-CT) technology to diagnose patients with life-threatening diseases, such as cancer and cardiac and neurological ailments.

PETNET Solutions, a fully owned subsidiary of Siemens Medical Solutions USA, operates the largest PET radiopharmacy network, with 49 radiopharmacies and distribution centers in the U.S., South Korea and the UK that produce and distribute PET radiopharmaceuticals to hospitals, clinics and research facilities for PET imaging.

The new facility in Chennai "will produce and supply the required radiopharmaceuticals to hospitals that have positron emission tomography-computed tomography facilities, which will help ease the burden of healthcare providers to produce their own radiopharmaceuticals," Siemens said.

The Indian facility will feature a Siemens Eclipse HP cyclotron and will be Siemens' first molecular imaging biomarker production facility in India.