|Boston Scientific Wins FDA Approval for IntellaTip MiFi XP Ablation Catheter; Incyte Issues Top-Line Results of Phase II PoC Trial of Ruxolitinib|
|By Staff and Wire Reports|
|Wednesday, 21 August 2013 19:37|
Boston Scientific Corporation (NYSE: BSX) continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath. These products join the company's growing portfolio of next generation EP tools designed to redefine ablation technology. Catheter ablation, a procedure in which localized electrical energy is delivered into the heart tissue and is aimed at restoring the continuous normal rhythm, has become a first-line treatment approach for patients with certain kinds of irregular heartbeats.
"The IntellaTip MiFi XP is a unique high resolution catheter which provides information that allows electrophysiologists to pinpoint locations for ablation, a key element needed for success," said Tom McElderry, M.D., director of Electrophysiology, University of Alabama Hospital. "In my experience with this technology, it proved especially useful in identifying areas of interest for diagnosis and ablation. This level of high resolution electrogram is something we have never seen before and I believe it will open a whole new array of possibilities in EP."
IntellaTip MiFi XP is indicated for ablation of atrial flutter, an arrhythmia that affects nearly one million people in the United States. The catheter features sophisticated mini electrodes on the tip designed to provide information about tip location and help clinicians assess lesion maturation and differentiate viable from non-viable tissue.
"Following the recent FDA 510(k) clearance of our novel Rhythmia Mapping System, adding the IntellaTip MiFi XP to our portfolio further reinforces our commitment to redefining ablation and diagnostic tools for the EP physician—especially since the catheter is compatible with the Rhythmia system," said Pete Sommerness, general manager, Electrophysiology, Boston Scientific. "We believe that the IntellaTip MiFi XP approval, combined with the introduction of our Zurpaz steerable sheath, demonstrates how we are delivering on our promise to provide electrophysiologists with meaningful innovation and complete solutions."
The Zurpaz 8.5F steerable sheath is cleared to gain access to the heart, facilitating placement of catheters for use in a variety of procedures including treatment of atrial flutter, atrial fibrillation and ventricular tachycardia. With enhanced features, including a soft distal tip, advanced shaft construction and an intuitive ergonomic handle, Zurpaz is designed to help clinicians deliver catheters consistently and safely during electrophysiology procedures.
Incyte Corporation (Nasdaq: INCY) announced top-line results of the Phase II, randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, its oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients with recurrent or treatment refractory metastatic pancreatic cancer. The hazard ratio (HR) for overall survival (OS) in the intent to treat population was 0.79 (one-sided p=0.12), and in a pre-specified subgroup analysis conducted in patients identified prospectively as most likely to benefit from JAK pathway inhibition, the HR for OS was 0.47 (one-sided p=0.005). Within this subgroup of patients, which represented 50% of the randomized population, 6 month survival in the ruxolitinib arm was 42% vs. 11% for placebo. Durable tumor responses were only observed in patients receiving ruxolitinib, and ruxolitinib treated patients achieved a significant improvement in body weight relative to placebo.
“Results of the RECAP trial provide the first evidence that JAK inhibition is active in this disease and suggest a demonstrable survival benefit in a well-defined group of patients with refractory metastatic pancreatic cancer who can be identified without the development of a companion diagnostic test. Coupled with the overall survival benefit observed in the ongoing Phase III trials in myelofibrosis, these results solidify our belief in the therapeutic opportunity that exists for Jakafi, and provide us with an acceleration strategy to advance our JAK1 inhibitor portfolio into additional areas of unmet medical need,” stated Paul A. Friedman, M.D., Incyte's President and Chief Executive Officer.
Richard S. Levy, Incyte's Executive Vice President and Chief Drug Development and Medical Officer added, “Advanced pancreatic cancer is a devastating disease, and the RECAP study has provided us with a unique opportunity to bring ruxolitinib forward into Phase III development in a population with no attractive treatment options. We look forward to working with the FDA to define the core components of the Phase III program in pancreatic cancer as rapidly as possible, and in parallel, leveraging these results to expand our ruxolitinib and JAK1 inhibitor programs into additional solid tumor populations, including those that may benefit from selective JAK1 inhibition.”
Full results of the RECAP trial are expected to be presented at a future scientific meeting.
Safety -- Ruxolitinib in combination with capecitabine was generally well tolerated in this study. Among patients receiving ruxolitinib plus capecitabine 12% discontinued therapy for an adverse event, compared with 20% who received capecitabine alone. The rates of new onset grade 3 anemia, thrombocytopenia or neutropenia were 16%, 2% and 0%, respectively, among patients receiving ruxolitinib plus capecitabine and were 2%, 3% and 2%, respectively, among patients receiving capecitabine alone.
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