03.18.14
Teleflex Incorporated has received U.S. Food and Drug Administration 510(k) clearance for restated Indications for Use of the EZ-IO Vascular Access System, a product it obtained through the acquisition of Vidacare Corporation.
The EZ-IO 25 millimeter needle set now can be used on patients 3 kg. (6.6 pounds) or heavier.
“In my clinical work in a free-standing, academic pediatric emergency department and level 1 trauma center, as well as in a large community hospital emergency department, rapid identification and treatment of serious conditions is paramount,” said Mark L. Waltzman, M.D., F.A.A.P., chief of pediatrics at South Shore Hospital and assistant professor in Harvard Medical School's pediatrics department. Waltzman also is affiliated with the Division of Emergency Medicine at Boston Children’s Hospital and is a paid consultant for Teleflex.
“The restated indication for the EZ-IO 25 millimeter needle set to be used in patients 3 kg. or over will help to avoid confusion and streamline care. Clinicians now will simply assess the tissue depth and choose the correct needle size. This is something we ‘in the trenches’ clinicians have requested from the company and I am gratified they have heard our feedback and pushed for this change,” Waltzman added.
New weight ranges for the EZ-IO Vascular Access System are now as follows:
“As part of our fight for zero complications in vascular access, we are committed to continuously improving our technologies, enhancing our training and educational initiatives, and partnering with healthcare professionals to provide solutions for treating difficult vascular access patients with the EZ-IO Vascular Access System,” said Jay White, president and general manager of Teleflex's Vascular Access Division. “We’re excited about the restated Indications for Use, because we’ve made it even easier for clinicians to select the right needle for their patient.”
Wayne, Pa.-based Teleflex makes a variety of devices for critical care and surgery.
The EZ-IO 25 millimeter needle set now can be used on patients 3 kg. (6.6 pounds) or heavier.
“In my clinical work in a free-standing, academic pediatric emergency department and level 1 trauma center, as well as in a large community hospital emergency department, rapid identification and treatment of serious conditions is paramount,” said Mark L. Waltzman, M.D., F.A.A.P., chief of pediatrics at South Shore Hospital and assistant professor in Harvard Medical School's pediatrics department. Waltzman also is affiliated with the Division of Emergency Medicine at Boston Children’s Hospital and is a paid consultant for Teleflex.
“The restated indication for the EZ-IO 25 millimeter needle set to be used in patients 3 kg. or over will help to avoid confusion and streamline care. Clinicians now will simply assess the tissue depth and choose the correct needle size. This is something we ‘in the trenches’ clinicians have requested from the company and I am gratified they have heard our feedback and pushed for this change,” Waltzman added.
New weight ranges for the EZ-IO Vascular Access System are now as follows:
- --- EZ-IO 45 millimeter needle: 40 kg. or over
- --- EZ-IO 25 millimeter needle: 3 kg. or over
- --- EZ-IO 15 millimeter needle: 3-39 kg.
“As part of our fight for zero complications in vascular access, we are committed to continuously improving our technologies, enhancing our training and educational initiatives, and partnering with healthcare professionals to provide solutions for treating difficult vascular access patients with the EZ-IO Vascular Access System,” said Jay White, president and general manager of Teleflex's Vascular Access Division. “We’re excited about the restated Indications for Use, because we’ve made it even easier for clinicians to select the right needle for their patient.”
Wayne, Pa.-based Teleflex makes a variety of devices for critical care and surgery.
Teleflex makes a range of devices for critical care and surgery. - See more at: http://dev.mpo-mag.com/issues/2013-06/view_breaking-news/teleflex-launches-next-generation-vascular-positioning-system/#sthash.0dO8ScXW.dpuf