Hansen Medical (NSDQ:HNSN) won a tentative FDA nod to dramatically scale down a clinical trial of its Artisan catheters paired with the Sensi X robotic system.
Hansen said the new study protocol will make it easier to enroll patients, which is has already started to do. The new study design must still be approved by an independent review board.
The news sent HNSN shares up 2.4% today to $1.72 apiece as of about 3 p.m.
Hansen is still reeling from tough 1st-quarter results that sent shares down 11% in a single afternoon. Mountain View, Calif.-based Hansen posted $17.2 million in losses, or 26¢ per share, on $3 million in sales during the quarter.
The company’s Artisan AF trial won IDE approval in 2010 and was originally intended to be a randomized study with 300 patients. The FDA gave Hansen conditional approval for the new, 100-patient protocol, but Hansen is allowed to begin enrolling now.
The study will examine the safety and efficacy of the Sensi X System for catheter placement in patients with atrial fibrillation. The new trial will look at major target performance measures including adverse events at 6 months and freedom from AF at 1 year.
“This study is an important step toward expanding our United States labeling to include use of our Artisan family of control catheters with our Sensei X Robotic System to navigate certain ablation catheters, and we believe this will be a positive factor in the growth of our US EP business given our expectation that the Artisan- AF study will enroll patients much more quickly than the previous study design," said CEO Bruce Barclay in a company statement.
