FDA clears Hotspur's new balloon dilatation and embolectomy catheters

Hotspur Technologies, Inc. announced today that it has received FDA clearance for the first three commercial products in its portfolio. These products are based on Hotspur's unique and groundbreaking technology that makes dialysis access interventional and peripheral vascular  procedures that open blood vessels less expensive, more efficient, and less invasive for patients.

These new Hotspur devices are focused on solving some of the key challenges resulting from two types of medical procedures for restoring bloodflow: opening the blood vessels or grafts needed by patients who have regular dialysis; and opening blocked vessels in arms and legs. In both of these instances, physicians must use multiple catheters to clear the blood vessels. Until now, these dialysis access interventions and peripheral vascular procedures have required insertion of a separate catheter. This is time-consuming and expensive. Hotspur's products enable insertion of only one catheter for the entire procedure.

"We are excited about the benefits our technologies will bring in peripheral and dialysis access interventions," said Gwen Watanabe, President and CEO of Hotspur Technologies. "Making peripheral vascular procedures faster and more efficient so that doctors can perform more cases and patients can get out of the interventional suite or the dialysis access centers more quickly is the focus of our innovations."

Watanabe further explained the need for these Hotspur devices:

In dialysis, when patients receive ongoing treatment, they regularly need to check and clean the access point for clots, damage, and limited access. Traditionally, this procedure requires multiple catheter insertions. With Hotspur, only one insertion is needed for the whole process resulting in reduced time and cost.

Peripheral arterial disease (PAD) and blood clots in the arms and legs affect more than 30 million people worldwide. PAD develops most often as a result of the hardening of arteries (atherosclerosis) which causes the arteries to narrow and restrict blood flow. This condition is most often treated with angioplasty, a minimally invasive procedure that uses a catheter and balloon to widen narrowed or blocked peripheral arteries. Unlike existing angioplasty balloons, the Hotspur devices enable physicians to conduct multiple functions with one catheter.

The three Hotspur products that have received FDA clearance are:

• The IQCath™ Balloon Dilatation Catheter is a specialty three-in-one device that allows a physician to conduct PTA, fluid injection, and perform thrombectomy while maintaining guidewire position. The IQCath Catheter is intended to be used within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.
• The GPSCath™ Balloon Dilatation Catheter follows the lead of the IQCath™ Balloon Dilatation Catheter and is a specialty two-in-one device that allows the physician to conduct angioplasty and fluid injection while maintaining guidewire position. It is intended to be used for angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
• The Keeper™ Embolectomy Catheter is another two-in-one device which integrates an embolectomy balloon with the ability to inject physician-specified fluids while maintaining guidewire position. The Keeper™ Catheter is intended to be used within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.

All three products are expected  to begin to be commercially available by the end of this year. They can all be used for dialysis applications. The IQCath and GPSCath Catheters are used for PAD procedures.  

Hotspur's unique and groundbreaking technology known as the VisioValve™ injection system is the foundation of these products. This innovation consists of a proprietary valve system that allows a physician to complete an entire angioplasty or clot treatment and perform an injection of 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.

"Hotspur's core technology is a breakthrough and with these newly approved products can already serve markets that are valued at billions of dollars a year," said Rob Kuhling, general partner of 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."