A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported Australian Therapeutic Goods Administration (TGA) approval of the Eon Mini neurostimulator, which the company calls "the world's smallest, longest-lasting rechargeable device in its class to treat chronic pain of the trunk or limbs and pain from failed back surgery."
In Australia, the Eon Mini neurostimulator is reimbursable via the private health system.
About the size of a matchbox, the Eon Mini neurostimulator is similar in function and appearance to a cardiac pacemaker. It delivers mild electrical pulses to nerves located near the spinal cord to interrupt or mask pain signals as they travel to the brain.
The Eon Mini has a 10 mm profile and weighs 29 grams (about 1 ounce). Its small size allows for a smaller incision, St. Jude said, giving the physician more control in selecting the optimal implant location.
The company said the device also has the greatest recommended implant depth of any small rechargeable neurostimulator. "For patients, the Eon Mini neurostimulator's thin profile, implant depth and small size allow the device to be placed more discreetly, potentially making it less noticeable and more comfortable."
"Device size and longevity are important considerations for many patients," said John Salmon, MD, specialist in pain management located at Bethesda Hospital (Perth, Western Australia). "Patients want a therapy that will control their pain, but they don't want the device to be noticeable. Our goal is to provide them with a device that is comfortable, as well as cosmetically appealing, while delivering sustainable therapy for many years."
"We are excited to be able to offer a best-in-class product to patients in Australia suffering from chronic pain," said Chris Chavez, president of St. Jude Medical's Neuromodulation Division. "Eon Mini is designed to provide physicians with more options in selecting a device that best meets the needs of their patients."
The company said the Eon Mini neurostimulator has the longest-lasting battery life of any neurostimulator currently on the market and is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the TGA. "This means the device should provide sustainable therapy and maintain a reasonable recharge interval for 10 years of use at high settings," St. Jude said. "The device's battery longevity also may mean that patients require fewer battery replacement surgeries."
The design of the Eon Mini neurostimulator is based on the proven platform of the Eon device and almost three years of performance data and improvements, the company said.
In addition to Australia, the Eon Mini neurostimulation system is available in the U.S. and Europe. More than 45,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.
More Thailand training by Cardima
Cardima (Fremont, California) said it has completed its second phase of training for cardiothoracic surgeons in Thailand on the use of the Cardima Surgical Ablation System, a closed-chest procedure for the treatment of atrial fibrillation (AF).
Cardima's electrophysiology product lines and Surgical Ablation System have received product registration approval in Thailand.
The three-day training session was performed under the direction of Li Poa, MD, chief of cardiothoracic surgery and cardiac surgery program director at Stamford Hospital (Stamford, Connecticut) and faculty member of Columbia University College of Physicians and Surgeons (New York).
Poa worked closely with Dr. Suchart Chaiyaroj, chief of cardiothoracic surgery at Ramathibodi Hospital (Bangkok) and a member of the faculty of medicine of Mahidol University, and his associate, Dr. Khanat Kruthkul.
Three patients were treated during this session, bringing the total number to seven patients treated using the Cardima Surgical Ablation System under the Thai training program.
Poa noted, "The Cardima system is capable of creating a fairly complete, complex lesion set for the minimally invasive surgical treatment of lone AF with the establishment of both pulmonary vein and antral isolation, ablation of the right-sided gangliae and posterior inferior vena cava, and a crossing closed-loop lesion of the coronary sinus isthmus."
He added that the Thai physicians who observed the procedures and participated in the training "were very impressed by the minimally invasive nature of the procedure, its ability to create complex and deep lesion sets, the speed at which it can be completed, the visualization available to surgeons and the fact that patients are discharged the following day. They are very supportive of our efforts to establish a strong AF treatment program, as well as an AF Center of Excellence in Thailand."
Several institutions and individuals have provided support for the development of such a Center of Excellence in Thailand.
Suchart is leading the training initiative on behalf of Ramathibodi Hospital, along with the support of Professor Rajata Rajatanavin, dean of the faculty of medicine, and others at both the hospital and university.
Cardima is focused on the treatment of AF with a product line that includes the Cardima Surgical Ablation System and the Revelation line of EP catheters.
New Singapore facility for Millipore
Millipore (Billerica, Massachusetts), a provider of technologies, tools and services for the global life science industry, has opened its Biomanufacturing Sciences and Training Center (BSTC) in Singapore.
The 8,000-square-foot facility will provide support and technical service to Millipore's biopharmaceutical customers who have operations throughout Asia.
"When many of our biopharmaceutical manufacturing customers began to establish significant operations in Asia, we saw a need," said Millipore Chairman/President/CEO Martin Madaus. "As our global customers expand in Singapore we need to be right there with them. This new facility continues and enhances the local support we have provided for more than 25 years in Singapore."
"Millipore's new regional training facility ... leverages Singapore's position as a strategic base for global biomedical sciences companies," said Beh Kian Teik, director, biomedical sciences, for the Singapore Economic Development Board.