Hotspur Technologies, Inc. announced today that it has received CE Mark approval for the IQCath Balloon Dilatation Catheter, allowing the company to introduce the novel technology to markets outside of the United States. The IQCath catheter utilizes Hotspur's groundbreaking technology to combine multiple functions into a single device that can potentially make procedures to open blocked blood vessels more efficient and cost-effective than current treatment options.
Over 2 million patients worldwide require dialysis due to end-stage renal disease (ESRD) with annual expenditures for dialysis products and services forecasted to be over $65 billion, making it one of the most costly segments of medical care. The need for continued dialysis to filter the blood of these ESRD patients results in repeated blockages within their vascular access sites. On average, these patients require multiple interventions each year in order to keep these sites free from blockages and subsequent clot formation.
These blockages are most often treated with standard balloon angioplasty, a minimally invasive procedure that uses a catheter and balloon to widen narrowed vessels. Unlike existing angioplasty balloons, the IQCath catheter enables physicians to conduct multiple functions that may be required to clear the blockage with a single catheter.
When treating blocked vascular access sites, physicians typically must use multiple catheters to restore blood flow by removing clot and opening the blockage. During a single procedure, these devices are removed and reinserted several times, which often proves to be time consuming and expensive.
The IQCath catheter is indicated for use within synthetic dialysis access grafts to remove embolic material and to dilate obstructive blockages. Based on the use of Hotspur's proprietary VisioValve technology, the IQCath catheter enables these functions to be performed with a single catheter, allowing a physician to perform balloon angioplasty, fluid injection, and thrombectomy while maintaining guidewire position. The ability to perform all three of these functions without removing the catheter can potentially enable use of a single Hotspur device to complete an entire procedure.
Currently, the IQCath catheter is one of three Hotspur products that is commercially available in the United States. Like the IQCath catheter , the GPSCath Balloon Dilatation Catheter and the Keeper Embolectomy Catheter also utilize the VisioValve technology to combine multiple functions into a single device. The GPSCath catheter is a specialty two-in-one device that is intended for both dialysis access and peripheral vascular interventions and allows the physician to conduct angioplasty and to inject fluid while maintaining guidewire position. The Keeper catheter is intended for use within vessels in the arterial system and is another two-in-one device, which integrates an embolectomy balloon with the ability to inject physician-specified fluids while maintaining guidewire position.
Hotspur expects to launch the IQCath catheter in select markets outside of the United States in the coming months as its network of distribution partners is finalized. CE Mark approval for the GPSCath catheter and the Keeper catheter is expected soon thereafter and will be followed by their international launch through Hotspur's same distributor network.
"We are excited about the benefits our technologies will bring to the world of dialysis access and peripheral interventions," said Gwen Watanabe, President and CEO of Hotspur Technologies. "Making these procedures faster and more efficient is the focus of our innovations. The initial response to our technologies has been extremely positive during our launch in the United States, and we look forward to sharing these products with physicians around the world."
"Hotspur's core technology is a breakthrough and, with this newly approved product, can already serve markets that are valued at billions of dollars a year," said Rob Kuhling, General Partner at ONSET Ventures, one of the company's early venture investors. "We are excited about what this can mean for doctors and patients worldwide and the potential for additional new treatments that are both easier to implement and much more cost effective based on this technology."
About Hotspur Technologies
Founded in 2008 and located in Mountain View, California, Hotspur Technologies (www.hotspur-inc.com) is a leading developer of catheter-based technologies aimed at restoring blood flow for patients with obstructed vessels. The company's products are based on a unique technology that opens blood vessels more efficiently and less invasively. The firm's VisioValve technology serves as a launching point to improve patient outcome and physician efficiency. Hotspur is privately held. Its investors include ONSET Ventures, Finistere Ventures, BioStar Ventures, Saratoga Ventures, Incept, GLevel, and Versant Ventures.
CONTACT: Gwen Watanabe, +1-650-969-3150, firstname.lastname@example.org
SOURCE Hotspur Technologies, Inc.