Medical

Elixir Medical Corp. (Sunnyvale, CA) has received CE (Conformité Européenne) Mark approval for a coronary scaffold system designed to degrade in about one year, returning the patients' coronary vessels to a normal condition. The DESSolve scaffold combines a proprietary poly-L Lactide (PLLA) plastic with an anti-proliferative drug called Novolimus.

Evidence continues to mount showing soaring use of plastics in medical implants, led by polyetheretherketone (PEEK).

As of February 2013,  the number of implantable medical devices manufactured from PEEK-OPTIMA and cleared for market in the US reached 500, with more than 80 approved for market in China, it was announced by Craig Valentine, director of regulatory affairs for Invibio.

One of my favorite places to try to find out what's going on in American medical care is a blog operated by the Columbia Journalism Review called "The Second Opinion: Examining Media Coverage of Heatlhcare". It's a blunt look at why we get so confused about medical costs, Obamacare, hospital ratings, and other subjects in the news. It's written by Trudy Lieberman, a former economics writer for Consumer Reports, and Sibyl Shalo Wilmont, a nurse and writer.

Here are some examples of their posts:

The drive to reduce medical costs in the United States is triggering more patient care in their homes, where costs are lower and there are reduced risks to acquire potentially deadly infections, such as MRSA and other penicillin-resistant bacteria.

A new "smart catheter" senses the start of an infection and automatically releases an anti-bacterial substance. It is being tested at the University of Michigan in an effort to stop catheter-related blood and urinary tract infections.

Dipankar Koley, the principal researcher on the project, said the technology can be applied to catheters inserted into blood vessels and the urinary tract.

Cleveland researchers are developing plastic-coated synthetic platelets that can be injected by first responders to save lives of wounded soldiers or crash victims in danger of dying from internal bleeding.

It's a product that could potentially have saved the life of Princess Diana who fatally injured in an auto accident in Paris in 1997. Battlefield and sports injuries can also cause severe internal bleeding.

According to a company with a vested interest in the situation, the newly imposed federal excise tax on medical devices is having an unfortunate consequence—relocation of manufacturing from the United States to Mexico. It's not a tax dodge—the tax still has to be paid. Moving to Mexico is a way to cut costs, according to an outfit called Co-Production International, a California company that is glad to help companies make the move.

TEQ Thermoform Engineered Quality is installing four Kiefel thermoforming machines, including two lines in a second ISO 8 level (Class 100,000) cleanroom at its headquarters plant in Huntley, IL, 50 miles northwest of Chicago.

Maxim Surgical (Richardson, TX), a recently established and privately owned designer and manufacturer of spinal implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for a cervical interbody fusion system made of machined polyetheretherketone (PEEK) rods.

The fusion system is hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae. The cervical spacer for the spinal fusion market is Maxim's first orthopedic implant.

In a sign of the times, two different papers at ANTEC last month explored the potential of improving manufacturing processes for plastic scaffolds used in tissue engineering—the synthetic production of new human organs.

One paper looked at use of injection molding microcellular foam, or MuCell, and the other looked at thermally induced phase separation (TIPS) because of its value in producing highly porous scaffolds with interconnected structures.