In Brief: Guidant Mini III
This article was originally published in The Gray Sheet
Executive Summary
Guidant Mini III: Shipments of the 48 cc, 90 g single chamber pacer/implantable cardioverter defibrillator are anticipated to commence in March. Guidant received FDA approval via premarket approval application supplement on Jan. 23 and will ramp up manufacturing capability prior to shipping, the firm states. The device is a smaller version of the firm's 59 cc, 115 g Mini II, and incorporates Guidant's new Quick Check and Quick Notes features which "allow the clinician to easily and quickly perform a comprehensive series of automatic tests and follow-up device operations" to facilitate patient management, Guidant states. The device uses Guidant's Endotak lead and Triad three-electrode energy defibrillation system...
You may also be interested in...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.