BridgePoint’s Chronic Total Occlusions Crossing System Gets EU Green Light

There’s a new hope for treatment of patients with completely blocked coronaries. BridgePoint Medical out of Plymouth, MN has announced winning the European CE Mark of approval for its Chronic Total Occlusion (CTO) Crossing System that consists of the Stingray® and CrossBoss™ catheters. The package, which has yet to receive FDA clearance, is designed to cross chronic total coronary occlusions in arteries, and reinstate myocardial blood flow through these difficult vessels.
From the press release:

“We have seen many attempts to implement new tools for the treatment of chronic coronary occlusions over the years, but until now none of them have provided any advantage over the current treatment of using specialty guidewires,” said Gerald Werner M.D. Ph.D., Professor at the Klinikum Darmstadt in Darmstadt, Germany. “This system is the first to provide a new option for the frequent situation when our guidewires do not reach the vessel beyond the occlusion. The BridgePoint system makes it possible to find the true vessel lumen and conclude the treatment successfully…”
In a prospective clinical trial conducted in the European Union and a post-market registry conducted primarily in South America the BridgePoint System was 67%-85% successful in placing an interventional guidewire beyond a chronic total coronary occlusion. Complications with the system were similar to general PCI and stenting.

The Stingray™ CTO Re-Entry System has two components: The Stingray™ CTO Orienting Balloon Catheter and The Stingray™ CTO Re-Entry Guidewire

Familiar coronary balloon catheter and guidewire designs are enhanced with custom features for CTO crossing without changing routine practice

Flat shape of the Stingray™ CTO Orienting Balloon Catheter is intended to orient one exit port automatically toward the vessel true lumen upon low pressure inflation (4atm)

The Stingray™ CTO Re-Entry Guidewire’s distal probe is designed for exit port selection and re-entry into the vessel true lumen

Bi-directional rotation of the proximal torque device with the FAST SPIN Technique is designed to aid in advancement of the CrossBoss™ CTO Catheter

A 3.0F atraumatic rounded tip is designed for passage through the CTO

The device is intended to cross directly through the CTO or bypass the obstruction via a subintimal path

We bet that cardiac surgeons, who are already straining from an assault of Plavix and stents, don’t want to know about these little cath trinkets.
Press release: BridgePoint Medical(R) Receives European CE Mark for Stingray(R) and CrossBoss(TM) for Opening Completely Blocked Arteries…
Product pages: CrossBoss CTO Catheter; Stingray CTO Re-Entry System
Flashback: BridgePoint Aims to Treat ChronicTotal Occlusions in Coronaries