Incorporating Serration Technology into a 40-year old Procedure

Angioplasty has been around for 40 years.  This procedure, which is used to restore blood flow in blocked arteries, has needed an upgrade for decades.  EuroPCR, the largest Interventional Cardiology conference in the world, is celebrating 40-Years of Angioplasty next month in Paris.  However, despite angioplasty’s long history, angioplasty balloons have not evolved enough to keep up with the changing landscape of arterial intervention, until now.

Serranator™ Alto PTA Serration Balloon Catheter

Cagent Vascular (Wayne, PA) received FDA 510(k) Clearance in February for the Serranator™ Alto PTA Serration Balloon Catheter for treatment of stenotic lesions in the leg arteries located above the knee.   The device has four stainless steel serrated strips embedded on the outside of the balloon.  The Serranator™ is the one and only FDA cleared balloon with Serration Technology designed to create linear, interrupted scoring inside the artery to aid arterial expansion. Fortunately for physicians, the Serranator™ is built on the same simple, familiar, easy-to-use platform as standard angioplasty.  The Serranator™ Alto is intended for use in the iliac, femoral, ilio-femoral and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

“A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries. Today, we are treating more complex lesions that require better tools.  We believe Serration Technology will prove to be effective in treating these complex lesions and will evolve into the new standard of care for vessel dilatation,” says Co-Founder and Vascular Surgeon Peter Schneider, MD.

“The concept of creating serrations is used across multiple industries. However, what is new is applying it to angioplasty. The Serranator™ is designed to create multiple longitudinal lines of interrupted micro-serrations to enable arterial expansion along those lines.”

Peripheral Artery Disease (PAD)

Peripheral artery disease (PAD) affected over 19 million people in the US in 2016[1].  PAD is caused by the build-up of plaque within the peripheral arteries, most commonly the leg arteries.  Atherosclerotic plaque within the artery walls can limit blood flow, therefore causing claudication or pain when walking.  Common treatments for PAD range from changes in diet and exercise to percutaneous transluminal angioplasty (PTA).  If PAD is left untreated, patients can develop critical limb ischemia (CLI) and in the most extreme cases, can lead to tissue loss and amputation.

Eighty two percent of physicians surveyed “strongly agree” that the peripheral arteries they are treating today are more complex than ten years ago. [2]  Lesion complexity usually refers to the length of disease and the amount of calcium or hard plaque found inside the vessel.  Increased rates of diabetes, obesity, and the aging population contribute to the rise of challenging PAD cases.

Patients with PAD will likely undergo an angioplasty procedure.  However, plain balloon angioplasty has its limits and doesn’t always produce a positive, long lasting result.  Flow-limiting dissections and residual stenosis are two of the most common negative effects of plain balloon angioplasty and often require the placement of a stent.  Plain angioplasty has proven itself in simpler lesions but isn’t enough for more challenging lesions that are calcified and longer in length.  New technologies like the Serranator™ will expand treatment options for physicians and have the potential to change the standard-of-care for the treatment of peripheral lesions.

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[1] Guggenheim Report, 2017.

[2] Cagent Vascular Marketing Research Survey, 2016.

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