A Medical Device Daily

Cardium Therapeutics (San Diego) and its operating unit, InnerCool Therapies, reported that InnerCool's RapidBlue endovascular temperature modulation system conforms to CE-mark requirements for use in inducing, maintaining and reversing mild hypothermia in a variety of clinical indications.

The approved indications include cardiac arrest, neurosurgery, fever, cardiovascular re-warming, trauma re-warming, plus potential additional applications including acute ischemic stroke and myocardial infarction.

The RapidBlue System is a thermal regulating system designed to manage and control patient body temperature. The system automatically cools or warms patients, as necessary, to maintain desired body temperature. It provides rapid or gradual temperature control for all patient sizes and its closed-loop, catheter-based system modulates body temperature without fluid introduction or exchange by circulating cool or warm saline within the interior of the catheter.

The company plans to begin selling the system in Europe and other countries that recognize CE-mark certification in the next quarter.

The RapidBlue System is under review for FDA 510(k) clearance.

"We believe our RapidBlue System is truly the most dynamic and best-in-class temperature modulation system on the market, and receiving CE-mark and UL [Underwriters Laboratories] certification demonstrates that the company has established and operates a world-class quality system," said Chairman/CEO Christopher Reinhard. "This is the first UL global certification for an endovascular thermal regulating system and further confirms the technology leadership position that InnerCool is establishing with the RapidBlue System."

Shortages a hindrance in bone graft sector

Improvements in bone grafts and cements have greatly increased the success rates of spinal surgeries and other bone graft procedures, global consulting firm Frost & Sullivan (F&S; London) says in a new report, European Markets for Bone Grafts and Bone Cements. The availability of a wide range of technologically superior bone grafts provides surgeons with the flexibility to choose suitable grafts for specific needs, increasingly making allografts the procedure of choice.

The F&S report says that the European market totaled $641.2 million in revenues in 2007 and estimates that it will grow to just under $1.5 billion in 2014.

"As manufacturing processes for machined bone become more efficient and are able to extract more value from the same limited supply pool, the number of units sold is expected to increase," says Frost & Sullivan Research Analyst Kezia Jasper. "New product designs attract more surgeons and thereby, boost revenues."

Jasper's report said patients and surgeons also prefer allografts for their other advantages — such as lower hospital and procedure costs, higher success rates, reduced morbidity, pain and blood loss, and better stability and rehabilitation.

Surgeons have been more apt to adopt the use of such grafts in the wake of increased numbers of published clinical studies backing the advantages of allografts. "They are further impelled by the availability of machined and standard bone grafts, since unlike autografts, they eliminate the need for an additional surgery," according to the F&S report.

Because the bones and organs used in allograft surgeries mainly come from donors who pledge their organs, the supply is impacted by the availability of such donations. The report said that with the numbers of donors remaining static for almost a decade, there is a crunch in supply of tissues and raw materials for processing.

"This public reticence to donate organs is due to a variety of reasons such as religious, social and emotional issues as well as inadequate awareness," F&S said. "Moreover, the availability of specific allografts in certain quantities is partly influenced by the number of donations that are processed."

The report says that non-profit organizations have had more success than have commercial entities in procuring tissues, since relatives feel less uneasy about donating a body to a non-profit organization than selling it to commercial organizations. To counter this situation, F&S said commercial companies need to establish agreements with non-profit tissue banks to procure tissue.

Advances seen in artificial veins/arteries

Researchers in London say they have taken a "major step" in making the use of artificial veins and arteries in coronary bypass grafts a reality. In a study published in the June issue of The FASEB Journal, the team describes how it developed the artificial graft tissue by combining man-made materials with human cells to make it elastic and durable, and so it can attach to host tissue.

"This advance could be a medical breakthrough that saves millions of lives around the world," said Gerald Weissmann, MD, editor-in-chief of The FASEB Journal. "Even more tantalizing is the successful fusing of living cells to nonliving substances that actually heal by forming a stronger bond to each other and to host tissue once put in use."

This, he said, "might even be called a start toward 'cyborg engineering.'"

"The notion that any body part could be engineered in a lab, attach to existing tissue 'naturally,' and grow stronger as it is being used is something thought completely impossible just 20 years ago," Weissmann said, adding that "it is only a matter of time before human tissues can be engineered to be at least as good as the originals, and this study moves us toward that reality."

In the journal report, scientists describe how they took an elastic scaffold — the material that gives the artificial graft its shape — of compliant polycarbonate urea urethane and incorporated human vascular smooth muscle cells and epithelial cells from umbilical cords.

They then took the artificial grafts and simulated blood flow in the laboratory to test their durability. They found that as the pulsing fluid flow slowly increased, the artificial graft's performance actually improved. The researchers hypothesize that this improvement is because the movement of fluid through the graft stimulates the smooth muscle and epithelial cells to release proteins that strengthen their ability to attach to the elastic scaffold and other tissues.

The report said coronary artery bypass grafting could benefit from such an approach, since current procedures are limited by the availability of healthy veins or arteries, as well as the patients' ability to survive both the vein-harvesting and artery-grafting aspects of the procedure.