A Medical Device Daily

Arbios (Waltham, Massachusetts) said it has engaged the British Standards Institution (BSI; London) —terming it "one of the leading notified bodies in Europe" — to assist the company in its effort to obtain a CE mark for its SEPET Liver Assist Device.

CE marking would allow sale of the SEPET — a sterile, disposable cartridge with proprietary membrane permeability characteristics for use in treating patients with chronic liver failure — within the 28 countries of the European Union and three additional countries in the European Free Trade Association.

"We ... look forward to advancing our market approval and product acceptance strategy for SEPET in Europe," said Shawn Cain, president/CEO of Arbios. "Based on guidance from BSI, we will seek approval of SEPET using data from our recently completed feasibility trial. If no additional clinical data are necessary, and if we meet all the requirements for CE marking, we believe that our CE-mark filing for SEPET will be completed by the beginning of 2009."

He added that the company is seeking a European distribution, marketing and sales partner to assist in introducing the product in Europe.

When a patient's blood is passed through the SEPET fibers, blood plasma components of specific molecular weights are expressed through the micropores, cleansing the blood of harmful impurities, including hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration.

These substances otherwise would accumulate in the patient's bloodstream during liver failure, causing hypotension, increasing risk of sepsis and accelerating damage to the liver, lungs and other organs such as the brain and kidneys — and suppressing the function and regeneration of the liver. SEPET is designed for use with standard blood dialysis systems available in hospital intensive care units.

Arbios said there currently is no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable via the provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions.

In addition to the SEPET device, the Arbios product portfolio includes the HepatAssist Cell-Based Liver Support System, a bio-artificial liver that combines blood detoxification with liver cell therapy to replace whole liver function in patients with the most severe forms of liver failure.

Gyro Knife receives CE-mark approval

GammaStar Medical Group (Shanghai, China) said that following more than a year of development, the company's Gyro Knife product for cancer radiotherapy has been awarded the CE mark.

Calling the action "a true milestone with a long-term strategic meaning for the group," GammaStar said the certification "shows the improved safety, effectiveness and advancement of the Gyro Knife in the eyes of the authorities of international markets." The company said the safety of the Gyro Knife "is ensured by its unique safety interlock mechanism."

Emergency stop switches are installed on the console and in the radiotherapy room, an interlock switch is installed on the shielding door of the radiotherapy room, a collision detecting switch is on the front end of the treatment head of the frame, plus limit switches for three movement directions of the patient support, as well as multiple interlock mechanisms such as voltage detecting interlock, detecting interlock for beam on/off failure, treatment mode interlock and timer failure interlock, all of which can ensure that the equipment is absolutely safe during usage.

The radiation source of the Gyro Knife has a double-layer sealed structure and "in the treatment room, there is an environmental detecting instrument, the alarm of which will ring when radiation of the radiation source exceeds acceptable standards," GammaStar said.

"At the same time," it added, "the operator is provided with a personal detection device of radiation levels and will test the equipment regularly to ensure safety and reliability of equipment and components."

GammaStar said the "superior dose distribution curve formed by three-rotary-focusing surpasses the Prague Peak' of the proton radiotherapy system, and reaches a new development level of SRS."

With the capital cost of the Gyro Knife equipment said to be roughly one-50th that of a proton radiotherapy system, the Chinese company said, "We believe this is a kind of advanced radiotherapy equipment that can be popularized."

GammaStar Group said it has signed cooperation agreements with medical units in more than 10 countries and plans to increase that number to more than 30 international collaborators this year.

CE mark for Israeli firm's stapling system

ES Vascular (Haifa, Israel) said it has received CE-mark approval for its Open Aortic Stapler (OAS) system for mechanical suturing of aortic synthetic grafts during open repair of AAA and other aortic reconstructions.

Based on the company's proprietary stapling technology, the OAS enables one-shot stapling of synthetic grafts to aorta in open repair of abdominal and thoracic aneurysmal and occlusive disease, replacing lengthy and cumbersome manual suturing in these major procedures.

"We are very pleased to have received the CE mark for our OAS device and will immediately implement our strategy to make it available in approved countries," said Shuki Porath, CEO of ES Vascular. "Positive clinical data position OAS to be a breakthrough product for patients and physicians alike."

Ralf Kolvenbach, MD, chief of vascular surgery and endovascular therapy at Augusta Hospital (Dusseldorf, Germany) and a principal investigator for the OAS clinical trial program, said, "OAS provides the construction of a geometrically perfect, uniform and standardized anastomosis that will not depend on the skills of the surgeon, is one of the principles lying behind the design of the OAS. This safety and feasibility trial showed that we now have the technology to use aortic stapling in a clinical setting."

He added: "The aortic stapler can create a uniform staple line between any synthetic vascular prosthesis and the aortic wall. It is a simple, safe, rapid and reliable technique to perform a sutureless, end-to-end anastomosis in patients with aortic aneurysms or occlusive disease."