Tangent Medical Gets FDA Clearance for the NovaCath
ANN ARBOR -- The Ann Arbor IV therapy product developer Tangent Medical announced it has received FDA 510(k) clearance for the NovaCath Secure IV Catheter System, an improved peripheral IV catheter design.
The company will be demonstrating NovaCath this week at the 2012 Annual Emergency Nurses Association Conference in San Diego.
"Up to 50 percent of all short-peripheral IV catheters develop complications that negatively impact catheter dwell times, clinical outcomes, patient safety and patient satisfaction," said Curtis Bloch, vice president of sales and marketing for Tangent Medical. "Our innovative, closed IV catheter design uniquely integrates advanced catheter stabilization, next generation tubing management, passive needle encapsulation and blood control on every short-peripheral IV start. Our research with clinicians has validated there is nothing like it in the market. FDA clearance will pave the way for us to advance the safety and efficacy of IV therapy."
The NovaCath Secure IV Catheter System integrates a series of next-generation technologies designed to address IV therapy challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort. NovaCath is the only peripheral IV catheter with advanced catheter stabilization designed to exceed the highest CDC, OSHA and INS standards for IV catheter stabilization. Its passive needle shielding technology and closed system design minimizes risk of needlestick injuries and occupational exposure to blood to the lowest feasible extent. Several novel design features uniquely position NovaCath to offer healthcare facilities uncompromising safety and satisfaction -- both to the clinician and the patient.
Tangent Medical recently unveiled its NovaCath Secure IV Catheter System at the Infusion Nurses Society Conference in Las Vegas and generated high levels of interest from clinicians and the industry. Attendees at the show marveled at NovaCath's integrated advanced catheter stabilization technology and the ability to eliminate an external "j-loop" based on its redirect of the fluid path internal to the device.
"Clinicians were quick to point out the novel design and benefits it would bring the practice of IV therapy, as well as patient and clinician safety," said Jeff Williams, Tangent Medical's CEO and chairman.
Founded in 2009 as a spin-out of the University of Michigan's Medical Innovation Center, the company's patent-pending NovaCath Secure IV Catheter System is the only safety IV catheter to cost-effectively integrate advanced catheter stabilization, passive needle encapsulation, tubing management and blood control. Based on extensive clinical research into the needs of both healthcare workers and patients, this next-generation system is designed to establish a new standard in catheter design, functionality and performance.
For more information, visit www.tangentmedical.com.
