Guidant Multi-Link Pixel
This article was originally published in The Gray Sheet
Executive Summary
First human implant of the coronary stent system for small vessels is performed July 11 at Sacred Heart Medical Center in Eugene, Oregon. The stent is intended to treat threatened abrupt closures of first-time or recurring blockages in small vessels with diameters of less than 3.0 mm. Separately, the firm has launched a multi-center safety and feasibility study to evaluate the AccuNet embolic protection system to reduce stroke during minimally invasive carotid artery stenting procedures. Guidant had submitted an IDE for the 50-patient study in May (1"The Gray Sheet" May 29, p. 3)
You may also be interested in...
HCFA Conditional Coverage For Clinical Trials Unlikely In Near-Term
The Health Care Financing Administration will not provide "conditional coverage" under Medicare for the ongoing REMATCH trial evaluating congestive heart failure treatment using Thermo Cardiosystems, Inc.'s HeartMate left ventricular assist device.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.