CE Mark For Teleflex’s Newly Acquired Vascular Access Catheter

“This clearance enables us to further advance a new standard of care in PICC catheters”

In short

Critical care and surgical device company Teleflex Inc. has announced that one of its seemingly myriad subsidiaries, newly acquired Semprus BioSciences, has gained CE mark for its Nylus™ Peripherally Inserted Central Catheter (PICC) with Semprus Sustain™ technology.

Background

Teleflex clearly believes vascular access products remain a market opportunity, now having the Arrow and Semprus businesses under its wing. According to Semprus, originally a spin-out from MIT, 56,000 annual deaths and $11.2 billion in infection and thrombus complication costs can be attributed to vascular access, facts that were clear drivers for the business and for Teleflex to pay an initial $30M for it in June of this year.

One of the expectations when making the acquisition was that the Nylus PICC would gain regulatory approval both sides of the pond, the first of which was always likely to be CE marking. The product uses a long-lasting polymer designed to reduce the attachment of platelets and blood proteins accumulating on its surface, thereby reducing one of the occupational hazards of vascular access devices. In a press release issued by Teleflex, the company claims this provides benefits to the patient, the caregiver and the health care system as it has been shown to reduce platelet adhesion and thrombus accumulation in the company’s in vitro and animal testing.

This approval comes hot on the heels of Teleflex announcing FDA clearance of ArrowADVANTAGE5 for central venous monitoring, developed by another of the company’s subsidiary businesses.

Company comments

“This clearance enables us to further advance a new standard of care in PICC catheters,” commented David L. Lucchino, Vice President of Semprus Technology, Strategic and Business Development of Teleflex. “Our novel technology, with its ability to work in blood products and long-term duration, holds great potential to reduce infection and thrombus-related complications for patients – while substantially decreasing associated healthcare costs.”

Source: Teleflex, Inc., Business Wire