A Medical Device Daily

AngioDynamics (Queensbury, New York) reported that the first percutaneous uses of irreversible electroporation (IRE) technology on liver and kidney lesions were conducted at The Alfred hospital (Melbourne, Australia), part of Monash University.

Using the company's NanoKnife system, Dr. Ken Thomson, professor and director of the department of radiology at The Alfred, performed a kidney case and two liver cases between Nov. 6 and Nov. 20.

The Alfred said that all three cases were "procedurally flawless" and encountered no safety issues. The hospital declared the first liver case successful, with the patient showing "clear improvement" after two weeks, with lesions decreased markedly in size.

The hospital said it intends to conduct further patient follow-up before determining final outcomes.

AngioDynamics' NanoKnife causes cell death by impacting the cell membranes with electrical pulses in targeted tissue, sparing nearby nerves, blood vessels, lymphatic systems, and other delicate structures. Targeted cells are removed by the body via blood vessels and lymphatic systems.

The company said this is different from thermal ablation modalities such as cryoablation, microwave and radio frequency ablation. "These modalities destroy all cells and critical structures in targeted tissue, leaving destroyed material in place for years," according to AngioDynamics. "The body can only remove it slowly and tediously by attacking from the outside, since all normal pathways to remove damaged tissue have been destroyed."

Thompson said, "Traditionally there [have] been a variety of methods used to destroy tumors, most of which cause damage to nearby healthy tissue. This technique does not affect the surrounding supportive tissues or nearby nerves and blood vessels."

He added, "With IRE, what I believe we're looking at is a whole new treatment modality that can be used on a wider spectrum of patients which potentially reduces risk or impact to their body. I believe the NanoKnife represents a new paradigm in radiologically guided microsurgery."

The hospital reported that each NanoKnife procedure comprised a sequence of 90 pulses, taking a total of about 45 seconds. Each procedure administered four to seven pulse sequences.

"These cases are part of our ongoing process to provide 25 NanoKnife systems to thought leaders like Dr. Thomson," said Eamonn Hobbs, president/CEO of AngioDynamics. "We are making excellent progress with the thought leader program, especially with the response we are getting from some of the world's leading cancer treatment institutions, and are excited about building the momentum of our commercial rollout by generating increasing amounts of data as additional clinical cases take place."

Philips to acquire Indian X-ray maker

Royal Philips Electronics (Amsterdam, the Netherlands) said it has reached an agreement to acquire Meditronics (Mumbai, India), a manufacturer of general X-ray systems targeting the economy segment in that country.

The transaction, which is subject to certain contractual and other conditions such as regulatory approvals, is expected to close in the fourth quarter. Upon completion of the deal, Meditronics will become part of the imaging systems business within Philips Healthcare (Best, the Netherlands/Andover, Massachusetts).

Financial details of the agreement were not disclosed.

The planned acquisition is Philips' second within the last three months of a healthcare equipment maker in India specialized in supplying products for the economy segment. Philips reported in early September the acquisition of Alpha, a manufacturer of cardiovascular X-ray systems.

"The acquisition of Meditronics, just two months after we announced the acquisition of Alpha, highlights our accelerating efforts to expand our healthcare business in emerging markets and India in particular," said Philips CEO Gerard Kleisterlee.

He added, "This underlines our ... decision to step up investments in these high-growth areas while also delivering on our commitment to supply affordable healthcare solutions in emerging markets."

Health Canada okays Cepheid SSTI test

Cepheid (Sunnyvale, California) said Health Canada has issued a medical device license for its Xpert MRSA/SA Skin and Soft Tissue (SSTI) test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus in skin and soft tissue infections.

Availability of the Xpert MRSA/SA SSTI test is expected to provide Canadian physicians and surgeons with a new tool to aid in selecting the most effective antibiotic therapy to improve patient management.

In less than one hour, the test processes specimens from suspected skin and soft tissue infection swabs to determine if a patient is infected with MRSA or SA. The new test runs on Cepheid's GeneXpert System, which the company terms "the world's leading healthcare-associated infection (HAI) molecular testing platform."

Rob Koska, Cepheid SVP of worldwide commercial operations, said, "The ability to accurately detect MRSA and SA in less than one hour is an important technological step forward in the management of both hospital-acquired and community-acquired infections."

A new six-year Queens University study, to be published in the December issue of the American Journal of Infection Control, says that more than 250,000 Canadian patients experience infected surgical wounds, blood infections and antibiotic resistant organisms while in the hospital each year. The study also states that, since 1999, rates of MRSA have more than doubled – from 2 per 1,000 hospital admissions across Canada to 5.2 per 1,000 admissions.

China Medical's FISH probe okayed by SFDA

China Medical Technologies (Beijing), a maker of in vitro diagnostic products, said it has received approval from the State Food and Drug Administration (SFDA) in China for its Breast Cancer HER-2 fluorescent in situ hybridization (FISH) probe.

The HER-2 FISH probe is designed to detect amplification of the HER-2 gene in human breast cancer tissue. HER-2, also known as HER-2/neu, is a gene that is notable for its prognostic role as well as the target of Herceptin, a drug for breast cancer treatment. Herceptin is effective in cancer patients whose HER-2 gene is over-expressed.

"We are excited to be the first company in China to receive SFDA approval for our FISH probes," said Xiaodong Wu, chairman/CEO of the company. "The approval enables us to initiate commercial promotion of our FISH probes."