A Medical Device Daily

SuperSonic Imagine (Aix-En-Provence, France) reported that it has signed an exclusive distribution agreement with Canon Marketing Japan (Canon MJ; Tokyo) to develop the Japanese market.

After receiving CE approval and 510(k) clearance from the FDA for its Aixplorer MultiWave Ultrasound System, SuperSonic Imagine has developed commercial networks on 4 continents and in more than thirty countries.

"The agreement with Canon MJ is quite important to us as it opens the door to one of the largest ultrasound markets in the world. In order to assess our product in this very competitive market, having Canon MJ as a partner is essential. I see our relationship with Canon MJ as a long-term collaboration extending potentially to other domains in the future. Aixplorer, with its unique disruptive technology, is well suited for markets looking for new innovative approaches," said Jacques Souquet, CEO of SuperSonic Imagine.

The Aixplorer is the only commercially available system of its kind with MultiWave Technology, which is based upon the interaction between conventional longitudinal waves and shear waves in tissue. The system consists of an all software-based architecture which provides both B-mode images and, for the first time, uses shear waves (ShearWave Elastography) to quantify true tissue stiffness or elasticity information in kilopascals. With MultiWave Technology, the Aixplorer brings clinicians significantly enhanced real-time diagnostic information that ther company said is quantitative and reproducible.

Sectra in Japanese mammography agreement

Sectra (Link ping, Sweden) reported a partnership agreement with Canon Marketing Japan (Canon MJ; Tokyo). Canon MJ will become a distributor of Sectra's digital mammography system, Sectra MicroDose Mammography, in Japan.

"Canon Marketing Japan is an ideal partner for the distribution of our mammography products, since the company is known throughout the world for its high quality standards, has a large existing customer base and a highly respected position in Japan," says Torbj rn Kronander, president of Sectra's medical operations. "This is a strategically important move to strengthen our operations in the second largest mammography market in the world."

"Sectra MicroDose Mammography, uniquely characterized by its photon-counting technology, was the obvious choice for us. Its exceptional characteristics offer unsurpassed low dose and superior image quality, which are crucial for success in the Japanese market," said Hiroshi Shibuya, Senior Managing Director of Canon MJ.

St. Jude reports 1st Chinese Eon implant

St. Jude Medical (St. Paul, Minnesota) reported that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.

The Eon neurostimulator, which is the first rechargeable spinal cord stimulator to be approved for use in China, was recently approved by the Chinese State Food and Drug Administration (SFDA) for the management of chronic low back pain and pain from back surgeries that have failed.

"Chronic pain is a serious health issue in China," said Professor Zhang De Ren, M.D., an interventional pain physician at the Shenzhen Nanshan Hospital of Shenzhen, Guangdong province who performed the procedure. "We are excited to be able to provide an advanced therapy such as neurostimulation in order to improve patient outcomes."

The Eon neurostimulator is designed to provide spinal cord stimulation therapy. Similar to a cardiac pacemaker, this "pacemaker for pain" delivers mild electrical pulses to a lead or leads that are placed in the epidural space near the spine to interrupt or mask the transmission of pain signals to the brain. Once activated, the system's programs are adjusted and fine-tuned to best manage the patient's pain.

"Implanting the first patient in China with a rechargeable neurostimulator represents an important step toward broadening the availability of this therapy," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division.

Neurostimulation patients can adjust the therapy by using a handheld device (similar to a remote control) that allows them to select from pre-set programs that are individually customized. Patients with a rechargeable Eon neurostimulator periodically recharge their devices, potentially resulting in fewer battery replacement surgeries.

In addition to the Eon rechargeable neurostimulator, the SFDA also approved the non-rechargeable Genesis neurostimulator. Non-rechargeable (also known as conventional) neurostimulators provide a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device.

Milestone in j-v with Chinese companies

Milestone Scientific (Piscataway, New Jersey) a developer of advanced injection technologies, reported that it had entered into a joint venture with China National Medicines Corporation (d/b/a "Sinopharm") and Yichang Humanwell Pharmaceutical Co., both incorporated in China, to develop orthopedic and epidural drug delivery instruments.

Milestone and its two j-v partners will establish a new joint venture entity for this purpose in the first quarter of 2010. The required initial funding for the new entity, estimated by the parties at $1.4 million, will be provided by the two companies, although Milestone will determine the proposed uses of their contribution. The j-v entity will utilize and adapt Milestone's proprietary CompuFlo technology for use in orthopedic and epidural drug delivery instruments. Milestone will own 50% of the j-v entity and the other parties will together own the remaining 50%.

"This new joint venture with two leading PRC pharmaceutical companies marks a significant step forward in Milestone's efforts to have its innovative computer-controlled drug delivery technology adapted for medical usage worldwide," said Leonard Osser, CEO of Milestone. "Preliminary studies have shown the effectiveness of using our CompuFlo technology for the alleviation of the pain associated with arthritic joint conditions and in providing accurate and more efficacious epidural anesthetic injections.