A Medical Device Daily

Globus Medical (Audubon, Pennsylvania), reported what it said is believed to be the first implantation of a total disc replacement device utilizing a posterior approach. The surgery was performed by Drs. Luiz Pimenta and Paul McAfee in Sao Paulo, Brazil.

"The Globus posterior TDR system is designed to restore disc height and return the pattern of motion to the neutral zone without compromising spinal stability or neurological integrity," said Pimenta, chief of spine surgery at Santa Rita Hospital (Sao Paulo, Brazil). "The procedure did not require a blood transfusion and the patient was able to leave the hospital the day after surgery."

McAfee, who is chief of spinal surgery at St. Joseph's Medical Center (Towson, Maryland), called the procedure "a hallmark event in the treatment of spine disease."

He said utilizing the posterior approach for total disc replacement (TDR) offers several advantages compared to the other options for TDRs:

  • It does not require an access surgeon.
  • It is a "much safer" procedure in that the iliac veins and inferior vena cava are protected.
  • "Bail-out" and revision procedures are much easier.
  • The ability to decompress the nerve roots "enables a much broader universe of suffering patients to have access to the benefits of TDR technology."

David Paul, CEO of Globus Medical, said the posterior TDR is the first of several advancements in motion preservation that the company will introduce in 2007. He said Globus intends to seek FDA approval to enter human clinical trials in the U.S. later this year, and is in the early planning stages of releasing the device for sale outside of the U.S.

Globus calls itself the largest privately held spinal implant manufacturer in the world, with more than $100 million in annual revenues. It has a portfolio of spinal fusion products, "growing initiatives" in biomaterials development and minimally invasive approaches, and said it is a leader in the development of motion-sparing technology.

IDSI revamps distribution in China

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida), a developer of laser optical breast imaging systems, said it has been disappointed by sales of its CT Laser Mammography (CTLM) system in China and has modified its distribution arrangements to accelerate market penetration of the system.

The company terminated its exclusive agreement with China Far East International Trading (CFET; Beijing) in order to appoint non-exclusive distributors and representatives in the country.

The CTLM system is a new continuous-wave laser breast imaging system that uses the latest technology and patented algorithms to create 3-D images of the breast. The company said the procedure is non-invasive, painless and does not expose the patient to radiation or require breast compression.

CEO Tim Hansen recently met with CFET representatives in Beijing to work out the details, and also visited breast imaging specialists in Beijing, Tianjin, Guangzhou, Hong Kong and Macau to discuss how CTLM might improve their practices.

"We had a nice start with CFET some time ago," Hansen said. "We earned the Chinese government's SFDA approval for the CTLM, sold several systems, and installed a CTLM at the Beijing Friendship Hospital to qualify for procedure payments under the Beijing healthcare system. We subsequently were approved for procedure payments."

He added: "In July 2006, with the encouragement of CFET and BAC, the company we hired to manage our Asian distributors, IDSI opened a representative office in Beijing and added marketing, administrative and service support personnel." But, said Hansen, "despite these moves, sales have not met our expectations."

He said the lack of sales in China has been "a huge disappointment," and said IDSI believes one of the causes may have been lack of market coverage and CTLM clinical awareness. "Our new approach will allow us to appoint distributors in multiple areas and work directly with luminaries and healthcare organizations."

The good news, Hansen said, "is that the breast cancer detection and treatment market in China is enormous, and our technology can play a vital role in delivering better and more effective breast cancer management tools to patients and clinicians."

In the U.S., Imaging Diagnostic Systems is seeking FDA pre-market approval for the CTLM system to be used as an adjunct to mammography. The system has received European CE mark, CMDCAS Canadian License and China SFDA approvals.

Parker Hannifin adds Asian firm

Parker Hannifin (Cleveland) reported the acquisition of Rayco Technologies (Singapore), an elastomer and seal technology company with compounding, mixing and precision molding capabilities that serve high-end medical and electronics markets. Terms of the deal were not disclosed.

Rayco occupies more than 176,000 square feet of manufacturing and office space in Singapore and China. Rayco revenues totaled about $26 million in 2006, and Parker Hannifin said earnings are expected to be accretive in the first full year of operation.

A provider of safety critical parts and miniature seals, the company has two locations that serve disk drive, electronics, medical, semiconductor, consumer and automotive markets.