“Alternative to x-ray” claim allows clinicians to adopt new standard of catheter location technology
Limerick, PA – Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technology products, today announced that its VasoNova Inc. subsidiary has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company’s VPS™ peripherally inserted central catheter tip location technology as an alternative to chest x-ray or fluoroscopy in adult patients when the guidance indicator shows a blue bullseye.
Currently, after most central venous catheters are placed, the correct location of the implanted catheter needs to be confirmed by chest x-ray, a process that is costly, time consuming, often repeated because of inaccuracy and which exposes the patient to radiation.
“VasoNova’s VPS™ system is a market-leading central venous catheter navigation technology. This clearance puts us in a strong competitive position and offers the potential to establish a new standard of care in catheter placement,” commented Benson Smith, Teleflex Chairman, President and CEO.
VasoNova VPS™ is the first system to use a combination of hemodynamic and other biometric data to calculate precise tip location and to communicate the position to the user via a simple graphical interface. The system provides the clinician with the opportunity to place the catheter correctly the first time, avoiding the need for confirmatory chest x-ray where indicated. This provides benefits to the patient, the care-giver and the health care system as a whole.
The VasoNova VPS™ system, comprising a portable console and a single-use bio-sensor that is compatible with all major makes of central venous catheters, is available now. The company began shipping product in January to hospitals in the United States.
About Teleflex Incorporated
Teleflex Incorporated (NYSE: TFX) is a global provider of medical technology products that enable healthcare providers to improve patient outcomes, protect against infections and support patient and provider safety. Teleflex, which employs approximately 12,500 people worldwide, also has niche businesses that serve segments of the aerospace and commercial markets with specialty engineered products. Additional information about Teleflex can be obtained from the company’s website at www.teleflex.com.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.