FDA grants clearance for wand device for testing blood vessel functions
SAN DIEGO The Food and Drug Administration has given clearance to access Scientific for its MicroAccess WAND, a device that allows clinicians to insert a sheath or catheter into peripheral blood vessels, Access announced Tuesday.
The San Diego-based company said the device, the first of several planned WAND devices, combines all the components of the modified Seldinger technique into one.
“The MicroAccess WAND is the first device to enable clinicians to perform the accelerated Seldinger technique, which we believe is the ultimate refinement in vascular access technology,” Access Scientific chief executive officer Steve Bierman said in a statement. “FDA clearance of the first version of the WAND marks a major step forward in making the accelerated Seldinger technique available to clinicians.”
Access Scientific said it primarily intends for the WAND to be used in interventional radiology suites and cardiac catheterization labs.
FDA grants orphan drug status to two non-Hodgkin’s lymphoma drugs
AMSTERDAM, Netherlands The Food and Drug Administration has granted orphan drug designations to Kiadis Pharma’s drug Reviroc for two types of non-Hodgkin’s lymphoma, Kiadis announced Monday.
The FDA granted one designation for diffuse large B-cell lymphoma and one for follicular lymphoma. The drug is under development for the elimination of cancer cells from an autologous graft in bone marrow transplants for end-stage blood cancer patients.
“This is an important strategic milestone in the development of Reviroc, and we are very pleased with the orphan drug designations received from the FDA,” Kiadis chief executive officer Manja Bouman said in a statement.
The FDA gives orphan drug designations to drugs developed for treating diseases and conditions affecting fewer than 200,000 people in the United States. The designation allows for accelerated review, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the U.S. after regulatory approval.
FDA approves Boostrix vaccine for use in adults
NEW YORK The Food and Drug Administration has approved a booster vaccine for use in adults, manufacturer GlaxoSmithKline announced Monday.
GSK developed the vaccine, Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed), for use in patients aged 10 to 18 as a protection against tetanus, diphtheria and whooping cough; the FDA’s new approval allows for its use in patients aged 19 to 64 as well.
The new approval follows two clinical trials of 3,000 adult patients.
Sanofi-Aventis makes a similar vaccine, Adacel, for use in patients aged 11 to 64.