FDA approval enables Biotronik to enter the crowded peripheral stent market

Astron stent--Courtesy of Biotronik

Germany's Biotronik entered the crowded peripheral stent market in the U.S., bagging FDA's stringent PMA approval for its Astron stent to treat peripheral artery disease in the common and external iliac arteries of the pelvis.

It's specifically indicated by the FDA "for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm."

The self-expanding stent is laser cut from a nitinol tube and carries four radiopaque extensions at each end. It's delivered using a standard delivery catheter and guidewire, the FDA explains on its website.

The Astron has been marketed outside the U.S. since 2003, and is also available in countries around the world, including Azerbaijan, Bulgaria, Colombia, France, India, Kuwait and Vietnam.

Approval was based on a non-randomized trial of 146 PAD patients in the U.S., Canada and Australia. The Astron demonstrated a 12-month major adverse event rate of 2.1%. The primary endpoint was a composite of stent and procedure related major adverse events, including 30-day mortality, target lesion revascularization (or repeat procedures) and limb amputation--which occurs in the most severe, untreated forms of the disease.

The Astron did not receive a panel review, indicating that it is fairly plain and simple for a high-risk PMA device.

Biotronik sells three other self-expanding peripheral stents outside the U.S. The company is also seeking U.S. approval of the Pulsar-18 peripheral stent. Unlike the Astron, that device is implanted in the lesions in the popliteal artery, located near the knee joint.

The therapeutic arena had been fairly staid, with drug-eluting stents making only a minor mark, compared to those for the coronary artery where they have replaced bare metal stents as the standard of care.

But Medtronic ($MDT) and C.R. Bard's ($BCR) recently FDA-approved drug-coated balloons are reshaping the PAD market. Physicians are increasingly aiming to nix peripheral stents altogether following standard angioplasty and deployment of the drug-coated balloons, which coat the lesions with paclitaxel.

That's because peripheral (or leg) stents are considered less effective than those implanted in the heart's coronary artery, in part because the constant movement of the legs puts pressure on the implants, sometimes leading them to fail or come unanchored.

Meanwhile, Abbott ($ABT) recently touted the cost-savings from its Supera peripheral stent, which the company claims is superior to other bare-metal stents because of its unique design and manufacturing process.

And Fierce 15 company Shockwave Medical aims to bring the next big innovation to the market with its CE-marked Lithoplasty balloon catheter that delivers a form of energy known as lithotripsy prior to performing standard angioplasty. 

- here's the approval letter and labeling from the FDA

Special Report: FierceMedicalDevices' 2015 Fierce 15 - Shockwave Medical