Stryker has announced the premarket approval (PMA) of the Neuroform Atlas stent system by the US Food and Drug Administration (FDA).
Neuroform Atlas—according to the company—is only the second aneurysm adjunctive stent to be granted PMA approval for the treatment of wide-neck, intracranial aneurysms in conjunction with embolic detachable coils.
The device was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval. However, PMA approval has now been granted based on robust clinical trial evidence proving the efficacy of the device, Stryker claims.
“Neuroform Atlas represents a significant advancement in the treatment of wide-neck aneurysms, which is now backed by the largest IDE [investigational device exemption] stent-coil trial completed to date,” said Osama Zaidat (Mercy Hospital, Toledo, USA), co-principal investigator of the US Neuroform Atlas investigational trial. “More impressive were the results, with an 84.7% primary efficacy rate, a 4.4% primary safety rate and a 3.8% retreatment rate.”
“Enhanced stent conformability, a low-profile delivery system and high deployment accuracy—even in distal anatomy—puts Neuroform Atlas in a category of its own,” added Brian Jankowitz (University of Pittsburgh Medical Center, Pittsburgh, USA), co-principal investigator of the study. “This product is changing my clinical practice by allowing more patients with difficult aneurysms an option at endovascular treatment while improving the quality and safety of treatment.”
Mark Paul, president of Stryker’s Neurovascular division, stated: “Proving the safety and efficacy of our products through landmark clinical trials is a top priority and key differentiator for Stryker. Meaningful clinical data enable our market-leading products to better serve patients suffering from debilitating cerebrovascular disease. PMA approval of the Neuroform Atlas stent system is a significant milestone in providing world-class technology to our physicians.”
