A Medical Device Daily

Acculis (Denmead, UK), which terms itself "the leading UK microwave ablation system company," reported the international release of its pioneering Microwave Tissue Ablation system for the coagulation of soft tissue in open surgery.

The FDA 510(k)-cleared device is the first microwave ablation system to offer large, fast spherical ablations from single-needle placements.

This launch follows the initial distribution in January to 14 cancer centers in the U.S., UK, Europe and Australia. The second stage entails another 30 cancer centers throughout the world that will collaborate along with the Phase One cohort in an audit of clinical use of the system and centralizing patient and treatment data. This clinical activity is being overseen by AUGIS, the UK HPB Surgeons body.

David Lloyd, consultant liver surgeon at Leicester Royal Infirmary who developed the microwave ablation machine and was the first to use the system in the UK, said, "The Acculis MTA System allows us to treat tumors in the liver quickly and decisively using a single probe. In some cases we are now able to treat tumors which otherwise would have been inoperable."

He called the system "a significant advance in the treatment of cancer," adding that it "appears to offer more effective treatment of liver tumors than lower-power RF or current microwave ablation systems."

Acculis CEO Stuart McIntyre said, "We are pleased to be making this market-leading technology available to cancer centers throughout the world. Our system is the first to meet surgeons' needs for 5 cm spherical ablations in four minutes without the need for complex multi-needle placements. This is just the first in a line of products that exploit our proven 2.45 gHz and 9.2 gHz microwave platforms."

The company said its system offers "large, fast and predictable performance with the ease of use associated with single-needle systems. The speed and predictability means that the desired coagulation zone can be reliably and decisively achieved, and the short time taken to create large coagulations means that many more sites can be coagulated within a given operative window."

Acculis added that "the simplicity of the system ensures that ablations can be performed during open procedures without placing complex additional equipment management demands on the operative team."

Acculis is part of the Microsulis group of companies.

ISO, GMP okays for Hoana Medical

Hoana Medical (Honolulu, Hawaii) reported that it has completed the intensive regulatory audits for CAN ISO 13485 and the J-GMP, which allows the use of the CAN ISO and GMP marks for its LifeBed Patient Vigilance System and expands the company's patient safety reach to include Canada and Japan.

The ISO and J-GMP marks are similar to FDA clearance and the CE mark, which Hoana previously acquired for U.S. and European markets, respectively (Medical Device Daily, Sept. 9, 2008). These are mandatory regulatory approval systems for all medical devices to be sold in Canada and Japan, which indicates that a product conforms to the relevant health, safety and environmental quality standards in those countries.

Traditionally, obtaining CAN ISO and J-GMP mark certification and approval is a 12- to 18-month process, but Hoana completed the certification process in less than six months.

"Obtaining the CAN ISO and J-GMP marks for the LifeBed Patient Vigilance System is another giant step toward bringing cutting-edge patient safety technology to countries with which we have close economic ties," said Hoana CEO Dr. Patrick Sullivan.

He added, "We have received tremendous interest in the LifeBed from hospitals in both Canada and Japan and will now be able to work with them to not only meet Joint Commission International's patient safety goals, but also improve healthcare. Patient safety is an international issue facing citizens of every country."

In Canada, a study showed that one in nine Canadians were victims of preventable medical errors and more than 24,000 people die each year from medical mistakes. In Japan, medical error figures are harder to come by because of the administrative reporting requirements and cultural barriers.

Medical errors in Japan are prosecutable in the criminal courts vs. the civil courts in the U.S., leading to fewer reported cases. Hoana said the government has acknowledged the need for dramatic improvements in patient safety and the need to find technological solutions on that front.

Hoana's technology transforms any hospital bed into a LifeBed, which invisibly tracks a patient's basic vital signs without any connection to the patient

Middle East sales start for BioElectronics

BioElectronics (Frederick, Maryland) said that its newly signed sales agent in the Middle East, Abdulkader Al-Mehyar Moh'd Basheer Halawy, has taken orders for roughly $400,000 in new sales in the region.

"We are pleased that the new agent has hit the ground running and is finding wide marketing acceptance for our products {and] we look forward to significant repeat sales as the product is distributed throughout the territory," said Farid Tamimi VP of international sales at BioElectronics. "There is strong demand for our ... products in the Middle East and other international markets."

BioElectronics is a maker of inexpensive, drug-free, anti-inflammatory medical devices and patches. The company's wafer-thin patches and devices contain an embedded microchip and battery that deliver pulsed electromagnetic energy, which it terms "a clinically proven and widely accepted anti-inflammatory and pain relief therapy that heretofore has only been possible to obtain from large, facility-based equipment.

BioElectronics sells its current products under the brand names ActiPatch and RecoveryRx, and said the dermal patch delivery system "creates a multitude of new product opportunities for chronic and acute inflammatory conditions."

No Comments