Abbott Braided-Wire Stent Wins FDA Approval

This article is originally published at Qmed.

Abbott Braided-Wire Stent Wins FDA Approval
Abbott Supera Peripheral Stent System

April 1, 2014 – (Qmed) Abbott Laboratories announced Friday that the FDA has approved its Supera Peripheral Stent System to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease.

The Supera stent has a unique, proprietary interwoven wire technology meant to mimic rather than resist the artery’s natural movement. Abbott acquired the technology last year through its $310 million acquisition of IDEV Technologies.

The FDA approval is specifically for treatment of blockages in the superficial femoral artery (SFA), a blood vessel in the thigh, and the proximal popliteal artery (PPA), a blood vessel above the knee.

Abbott officials tout the Supera’s stronger, kink-resistant properties as especially important in such arteries, which experience a great deal of movement amid the sitting, walking and standing that takes place on a given day.

Here’s how Christopher Owens, then-CEO of IDEV, described the Supera to MPMN in 2012:

“Supera is designed from six wires that are woven around a mandrel to create a stent structure. This stent structure exhibits both strength and flexibility. Because of this feature, it has the ability to adapt to and mimic vessel anatomy. In contrast, nearly all other stents in the marketplace start from a stiff hollow tube. Those stents are laser cut from the tube, and the final design does not enable the device to exhibit a high level of both strength and flexibility. Thus, if you want more strength, you have to leave metal in, but you then lose flexibility. And if you want more flexibility, you have to take metal out, but you then lose strength. …

“The stent is made from nitinol, which does not differ from the material used to manufacture other stents. What is different about our stent is the design. Instead of using a tube, we start with six nitinol wires and braid them around a mandrel in a tubular design to form a closed-cell structure. Then, the device is shape-set at high temperatures and subjected to multiple proprietary heat-treating processes that permanently force the wire braid to conform to a certain geometry. Then, the stent is finished by removing the heavier nitinol oxide, leaving behind a uniform passivated titanium-rich oxide that exhibits excellent biocompatibility and corrosion resistance.”

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.
This article is originally published at Qmed.


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