FDA clears Jetstream Navitus for treatment of peripheral vascular disease

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The Jetstream Navitus (Pathway Medical Technologies) offers greater flexibility, unsurpassed cutting effectiveness and improved guidewire performances. This catheter is a highly effective option for treating calcium blockages and chronic total occlusions in the peripheral vascular disease patient population. 

The US Food and Drug Administration (FDA) has given 510(k) clearance to Pathway Medical Technologies to market its Jetstream Navitus, an enhanced revascularisation catheter for the treatment of peripheral vascular disease.

 

The Jetstream Navitus offers greater flexibility, unsurpassed cutting effectiveness and improved guidewire performances. This catheter is a highly effective option for treating calcium blockages and chronic total occlusions in the peripheral vascular disease patient population.

 

“The Jetstream Navitus offers interventionalists an evolutionary new tool to treat the most calcified lesions in the infra-inguinal vascular space,” said Andrey Espinoza, medical director, Hunterdon Medical Center, New Jersey, USA. “The design iterations provide a superior cutting platform with enhanced flexibility and an excellent deliverability profile. The Jetstream Navitus will allow a wider spectrum of patients to benefit from this generational technology.”

 

Jetstream Navitus’ features:

 

• Improved performance in tortuous anatomy—Enhanced drive line design provides for coaxial guidewire movement through the length of the catheter, offering enhanced flexibility, reduced friction and smooth movement through the curves of the peripheral vasculature.

 

• Highly effective therapy for calcium and chronic total occlusions—Navitus provides front-end cutting and unsurpassed differential cutting effectiveness that make it ideal for treating even the most difficult and substantial blockages.

 

• Active aspiration—The Jetstream family of products remain the only atherectomy devices on the market to offer active aspiration. This feature allows the operator to continually aspirate excised tissue and thrombus while the device is operating. Unlike other competitive products that require users to stop treatment and empty collection chambers or simply deposit debris in the arterial beds downstream, Jetstream’s active aspiration is an important safety feature that both reduces procedure time and minimises the risk of distal embolization.

 

• Single device solution—Navitus features expandable blade technology that enables treatment of blockages from the superficial femoral artery to below the knee, empowering physicians to treat all lesion morphologies.