Boston Sci receives FDA and CE mark approval of its thrombectomy catheter for deep vein thrombosis

AngioJet ZelanteDVT thrombectomy catheter--Courtesy of Boston Scientific

Boston Scientific ($BSX) announced simultaneous approval to market its AngioJet ZelanteDVT thrombectomy catheter for treating deep vein thrombosis in the U.S., Europe and other countries that accept the CE mark.

In the U.S. it was cleared via the 510(k) pathway for low- to moderate-risk devices with a substantially equivalent predicate device on the market.

Boston Scientific says it's the first catheter in its AngioJet franchise designed specifically to treat deep vein thrombosis, and has four times the thrombus removal power of current AngioJet devices. The line was acquired from Bayer for $415 million in 2014.

The ZelanteDVT is designed to remove large venous clot burdens and facilitate rapid restoration of blood flow in large-diameter upper and lower limb peripheral veins (at least 6 millimeter in diameter), according to a release.

"The new features of the ZelanteDVT catheter represent our focus on improving procedural efficiencies and reducing the economic burden associated with this challenging condition," said Jeff Mirviss, president of Boston Scientific's peripheral interventions unit in a statement. "With this addition to our AngioJet portfolio, we are further evolving the current suite of life-changing therapeutic options available to physicians and their patients with deep vein thrombosis."

Dr. Mitchell Silver, the first doctor in the U.S. to use the ZelanteDVT in a deep vein thrombosis procedure, added in a statement that the device could decrease bleeding risks and patients' need for intensive care stays.

The device is inserted at the site of the blocked vein using a delivery catheter and guidewire. It then breaks the blood clot, or thrombus, into smaller pieces and collects it within the body of the device prior to removal, according to an illustrative company video.

Deep vein thrombosis affects up to 2.5 million people in the U.S. and Europe annually, often leading to hospitalization, Boston Scientific says. The condition can be fatal if a clot breaks free of the blockage in the vein and travels in the bloodstream to the lungs, resulting in a pulmonary embolism.

Blood thinners are also used to treat deep vein thrombosis.

The ZelanteDVT is the latest addition to Boston Scientific's line of AngioJet thrombectomy offerings, which also includes the FDA-approved AngioJet Ultra Thrombectomy System for the removal of thrombus from the heart's coronary artery.

The simultaneous approval also marks a win for the FDA's newfound emphasis on speed. The agency usually lags years behind its European counterpart when it comes to the approval of devices.

- read the release