• Aspect Medical Systems (Norwood, Massachusetts) reported the introduction of the new LiDCOrapid advanced hemodynamic monitoring system. The LiDCOrapid is a minimally invasive cardiac output monitor designed for use in the operating room to provide clinicians with accurate and immediate feedback on the patient's fluid and hemodynamic status. The LiDCOrapid system, comprised of a monitor and single-use disposable, provides flow-based hemodynamic monitoring information that Aspect claims is ideally suited for high risk patients and procedures or when optimal fluid management requires more information than can be obtained from standard blood pressure data alone.
• DSM PTG (Berkeley, California) reported the availability of Bionate II PCU, a medical polymer with built-in surface technology designed for chronic implants. DSM says Bionate II PCU is a line extension of the Bionate Polycarbonate Urethane family, one of the industry's leading medical polymers for long-term implants and is backed by an established FDA Master File. The new polymer offers improved performance and processing characteristics for medical devices. It includes SAME technology, a built-in surface modification using surface activity and self assembly of chemical groups attached to the ends of each polymer molecule during synthesis. This technology enables medical devices to be equipped with permanent surface modification while maintaining excellent mechanical properties. It can also eliminate the need for secondary surface treatments once a device is made.
• e-Zassi.com (Fernandina Beach, Florida) said it has released its U.S. Regulatory Calculator as a stand-alone tool to give users an analysis of the FDA classification of up to three separate medical technologies along with a one-year membership in the e-Zassi medical device industry network. The calculator is software powered by a current database of information on classified medical devices. Anyone involved with medical devices – from researchers to engineers, technology transfer agents, business development officers, medical device companies and investors – can use the new FDA Regulatory Calculator by inputting non-confidential product attributes and physical details about their new product or technology. The calculator searches and provides the potential predicate codes and other regulatory information.
• Merge Healthcare (Milwaukee) introduced a new anesthesia information management solutions portfolio. Merge says this portfolio uses forms-based electronic templates, flexible software and user-friendly tools that reduce documentation time, improve data accuracy and charge capture, and allow for hospitals to make a rapid transition from paper-based systems to electronic systems that can seamlessly integrate with a patient's electronic health record. The product line includes: Frontiers 4.3 for anesthesia information management solution/perioperative care information management solution; Frontiers Sidecar used to document procedures within the electronic Frontiers chart; and Frontiers Patient Portal designed to simplify the pre-surgical testing process.
• Starch Medical (San Jose) reported the first controlled clinical intro/launch of SealFoam Absorbable Polysaccharide Hemostat. The company says that SealFoam is the latest addition to the Absorbable Modified Polymer (AMP) product line and offers a hemostatic foam (pad) configuration for a wide range of surgical wounds. The ultra hydrophilic and adhesive properties of SealFoam are especially formulated to control oozing or profuse bleeding, and to minimize the possibility of re-bleeding. The pad may also be trimmed to suit the surgical procedure and is indicated for a diverse range of applications and unique wound contours. AMP technology is an engineering process that modifies plant starch into biocompatible, absorbable, hemostatic polysaccharide particles. AMP particles have a molecular structure that rapidly absorbs water from blood, causing a high concentration of platelets, red blood cells and coagulation proteins which accelerate the physiologic clotting cascade at the bleeding site.
• Wright Medical Group (Arlington, Tennessee) reported the launch of the Dynasty Biofoam Acetabular Cup System. This latest addition to the Dynasty system features bone-like titanium with a roughened texture that "bites" into bone for enhanced immediate fixation when compared to traditional porous beads. The Biofoam material also features a trabecular structure intended to mimic bone and contribute to bone in-growth and biological fixation. Wright claims the Dynasty Biofoam Acetabular Cup System represents the debut of its Cancellous Titanium technology within its line of hip products.