• Baxter Healthcare (Deerfield, Illinois) reported FDA approval of the Gelfoam plus hemostasis kit (absorbable gelatin sponge, USP and human thrombin). Gelfoam Plus is the only available hemostasis kit that contains Pfizer's Gelfoam brand plus Baxter's Thrombin (human) for use in controlling bleeding during surgical procedures. Gelfoam Plus hemostasis kit is indicated as a hemostatic device for surgical procedures when control of capillary, venous, and arteriolar bleeding by pressure, ligature and conventional procedures is ineffective or impractical. Human thrombin used without the Gelfoam sterile sponge is not indicated for hemostasis. Baxter's human thrombin is made from human plasma. Gelfoam is a sterile, pliable, surgical sponge prepared from specially treated, purified gelatin solution and capable of absorbing and holding within its meshes many times its weight in whole blood. It is used as a hemostatic device.
  • GlucoLight (Bethlehem, Pennsylvania) reported design and performance enhancements to the company's first product, the Sentris-100 glucose monitor. The enhancements to Sentris-100 include changes in both design and functionality. The new sensor features increased sensitivity to changes in blood glucose levels, using a single sensor that is comprised of a multiple optical sensor network. The company has effectively miniaturized many of the components of the sensor, totaling a 50% reduction in weight and size, and improving the ergonomics of the sensor for greater patient comfort. GlucoLight makes non-invasive blood glucose monitoring in the acute care environment.
  • Integra LifeSciences (Plainsboro, New Jersey) reported that it has launched Integra Flowable Wound Matrix which recently received FDA 510(k) clearance. The wound care device's design is based on Integra's collagen technology and provides an alternative to filling deep soft tissue or tunneling wounds in diabetic foot and venous leg ulcers. When hydrated with saline, the matrix forms a gel that can be applied to difficult-to-access wound sites and provides a scaffold for cellular invasion and capillary growth. The Integra collagen-glycosaminoglycan matrix, originally developed for Integra Dermal Regeneration Template, has been modified into a flowable form to close difficult, irregular wounds, according to the company.

No Comments