JEFFERSONVILLE, Ind.—Freudenberg Medical has released three new technologies to the market aimed at medical device companies.
The FlexSeal Intruducer Sheath, FlexSeal Hemostasis Valve and Composer Deflectable Catheter Handle Platform were introduced at the recent Trans-catheter Cardiovascular Therapeutics Conference in Washington. Freudenberg said each product is designed to help medical device manufacturers accelerate time to market, access new design options to improve catheter and delivery systems, or reduce time when building new features into products.
The hemostasis valves in both the FlexSeal and Composer utilize silicone components.
“These three new technologies are the direct result of our desire to proactively address the growing innovation gap in medical devices and help our customers accelerate their time to market,” Bernhard Kaeferlein, Freudenberg Medical's director of portfolio management, said in an email.
“We focus on identifying, developing and commercializing cost effective medical devices, designs and processes in markets with a high need for innovation, disruption and growth. The FlexSeal and Composer technologies were developed to address key clinical and technical needs in vascular access and therapy delivery.”
The FlexSeal Introducer Sheath enables support access for large bore catheter procedures. Kaeferlein said it was designed to provide firms with a complete technology solution to improve procedural work flow, hemostasis, kink resistance and trackability in large bore vascular access. He added that the lack of a complete technology solution was the primary market need behind this project.
Large bore procedures are growing rapidly in number of cases, applications and complexity, Kaeferlein said. The new product helps customers fill a void within an existing product portfolio.
Freudenberg said the FlexSeal Hemostasis Valve greatly improves hemostasis performance when integrated into next-generation catheter or delivery systems. Kaeferlein said the product brings the same technology from the introducer sheath that customers can integrate into their next-generation catheter or delivery system to improve procedural work flow and hemostasis performance. He said there were essentially no off-the-shelf solutions that offered the same variety of features as Freudenberg's new valve.
Finally, the Composer Deflectable Catheter Handle Platform offers customers a commercialization ready, modularized and versatile design technology that can help reduce project lead times and costs while adding next-generation features into product lines that utilize catheters, introducer sheaths and delivery systems.
Kaeferlein said that traditionally, the most challenging part of deflectable catheter development is shaft performance. Composer was developed to allow engineering teams to focus on shaft development and reduce project lead times by starting with a commercial-ready control handle suitable for a broad range therapeutic and device delivery applications, he added.
“The FlexSeal and Composer technologies will continue to keep us and our customers busy for the foreseeable future,” Kaeferlein said. “However, we won't be resting on our early successes. There is no shortage of clinical needs or ideas in the medical device space. Over the next several years, we will continue rolling out completely new technologies as well as innovative line extensions and iterations.”