First commercial deployment of Hotspur GPSCath Balloon Dilatation Catheter

Hotspur Technologies, Inc. announced today that Dr. Bruce Lin, M.D., and Dr. Stephen Liu, M.D., Interventional Radiologists at Lifelink Interventional Center in Modesto, California, performed the first commercial deployment of the company's GPSCath™ Balloon Dilatation Catheter.  This new device enables, for the first time, multiple vascular procedures to be performed with one catheter, potentially reducing procedure time and expense for both patients and medical professionals.  

The GPSCath™ is a two-in-one device that allows physicians to perform high-pressure angioplasty and inject physician-specified fluids such as contrast while maintaining guidewire position.  

"The Hotspur GPSCath™ balloon is a superior alternative to a non-compliant ultra-high-pressure legacy devices currently in use," said Dr. Lin. "This is because the flexible nature of the Hotspur device allows tactile and visual feedback on the stenotic lesion, while still providing the performance of a ultra-high-pressure angioplasty balloon.  In addition, the value added feature enables operators to conveniently maintain guidewire position while delivering therapeutic drugs and evaluating results of interventions. This is especially attractive when treating difficult or occlusive lesions.  Hotspur is setting a higher bar for peripheral and dialysis access angioplasty performance."

During the first procedure, Dr. Liu successfully restored blood flow through the patient's dialysis access graft by inflating a 7mm GPSCath™ balloon to 20ATM to open a blockage within the graft.  After performing the angioplasty, without removing the balloon, Dr. Liu then opened the proprietary valve on the distal end of the GPSCath™ balloon catheter and successfully injected contrast to visualize the angioplasty result. Dr. Liu followed with a second procedure performing both functions utilizing a 6mm GPSCath™ balloon. In the past for these types of treatments, physicians typically had to perform multiple catheter exchanges to open the vessels and visualize results, which can be time-consuming and expensive due to the use of multiple catheters. Hotspur's products aim to use one catheter for the entire procedure.

"We are committed to enabling medical professionals to perform peripheral access procedures with devices that both simplify and improve the doctors' and patients' experiences," said Gwen Watanabe, president and CEO of Hotspur.  "Our key goal is to bring innovation to markets that have had less focus because they are so fragmented."  Watanabe indicated that, based on recently released data, there are almost 20 million patients with peripheral vascular disease that could benefit from this multi-purpose approach to catheter design for the peripheral access market.

The GPSCath is the one of three Hotspur devices that have received 510(k) clearance from the U.S. Food and Drug Administration.  These devices are focused on solving some of the key challenges associated with restoring blood flow to blocked or low flow dialysis access grafts and fistulaes and peripheral vessels. In addition to the GPSCath™, the IQCath™ Balloon Dilatation Catheter is a specialty three-in-one device that allows the physician to perform angioplasty, embolectomy, and fluid injection with the same catheter while maintaining guidewire position; and the Keeper™ Embolectomy Catheter is a specialty two-in-one device that integrates an embolectomy balloon with the ability to inject physician-specified fluids while maintaining guidewire position.

These products are commercially available in the United States. The foundation of Hotspur's commercial devices is a groundbreaking technology known as the VisioValve™ injection system. This innovation utilizes a proprietary valve system that allows a physician to perform angioplasty or clot removal and perform an injection of physician-specified fluids without having to remove the guidewire or exchange devices. Hotspur expects to develop a variety of other treatment devices based on this technology.