Navigation Links
Avalon Laboratories receives FDA and European clearances to market three catheter devices
Date:1/15/2009

Los Angeles, Calif. January 15, 2009 Avalon Laboratories, LLC (Avalon) today announced it has received 510(k) clearances from the U.S. Food and Drug Administration (FDA) and CE Mark acceptance from the European Union for three new catheter devices used in medical life support systems. The clearances enable Avalon to begin distributing these products to hospitals and health care systems in the United States and the European Union. The company also was issued U.S. Patent No. 7473239 for a Single Expandable Double Lumen Cannula Assembly for Veno-Venous ECMO, on January 6, 2009.

Avalon's Elite catheters utilize an embedded wire layering technology to resist collapsing and kinking, and are constructed with Avalon's Elast-Eon copolymer that combines the biostability of silicone with the strength and durability of polyurethane. Both devices feature the Avalon Elite Introducer System, the patented integrated catheter and introducer design that makes it easier for health care providers to insert and position the device. Avalon's Elite Vascular Access Kit provides uniquely designed accessories to aid the use of its Elite catheters.

"The Avalon Elite line enables health care providers to evolve and improve the way patients are connected to critical life support devices," said Robert Foster, chief executive officer of Avalon Laboratories, LLC. "These regulatory clearances will provide new options for critically ill patients suffering from lung failure. We have worked very hard over the last three years to bring these important new devices to market; it is hugely satisfying for all of us at Avalon, to see patients benefitting from our efforts."

The clearances apply to the Avalon Elite Bi-Caval Dual Lumen Catheter (DLC), the Avalon Elite Multi-Port Venous Femoral Catheter and the Avalon Elite Vascular Access Kit.

Avalon Elite Bi-Caval Dual Lumen Catheter (DLC)

The Avalon Elite DLC is indicated for use as a single catheter for simultaneous venous drainage and re-infusion of blood via the internal jugular vein during extracorporeal life support procedures. The DLC is designed to increase the efficiency of blood gas exchange by draining blood from both the upper and lower body while simultaneously reinfusing it directly into the heart. The device is more efficient and less traumatic for patients than previously available devices.

Because it is designed to be inserted through the skin, the external diameter of the DLC is gradually tapered to promote smooth insertion. This advanced catheter is wire-reinforced to resist kinking and collapsing and is offered in seven different sizes to accommodate use in patients from infant and pediatric to adult. Currently available DLCs are cleared for use only in small children, and can result in significant recirculation, insufficient venous drainage and problems with kinking and collapsing which lead to insufficient gas exchange.

Avalon Elite Multi-Port Venous Femoral Catheter

The Avalon Elite Multi-Port Venous Femoral Catheter incorporates advanced materials and physician-focused engineering to make it flexible, kink resistant and high performing. The catheter is offered in five sizes to better match the needs of individual patients. Blood drainage is optimized with multiple strategically placed, wire-reinforced ports. This catheter's design improvements facilitate vascular insertion, enhanced placement and uninterrupted support and performance.

Avalon Elite Vascular Access Kit

Accompanying these devices is the Avalon Elite Vascular Access Kit, designed to help health care providers insert catheters and cannulae wherever they are needed. The kit provides an assortment of patented small- and large-bore Avalon Elite dilators, designed with thin, flexible tips and robust proximal shafts to enable precise guide wire tracking and smooth, gradual vessel dilation.


'/>"/>

Contact: Rebecca Howe
rhowe@lambert-edwards.com
616-233-0500
Lambert, Edwards & Associates
Source:Eurekalert  

Related medicine news :

1. Avalon Pharmaceuticals names lead development candidate in beta-catenin inhibitor program
2. iCan Benefit Group, LLC Announces: Major Medical Division Now Offers Avalon Healthcare Products
3. Avalon Portfolio Nominates Slate of Directors for TomoTherapy Board
4. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
6. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
8. Sandia National Laboratories Selects Allscripts Electronic Health Record and Practice Management for Employee Health Center
9. Andrew Lessmans TWC Construction and ProCaps Laboratories Contract With DT Solar to Install a 700 kW Solar Electric System
10. Mesa Laboratories Names New Vice President of Sales and Marketing
11. Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Avalon Laboratories receives FDA and European clearances to market three catheter devices
(Date:5/23/2017)... ... May 23, 2017 , ... The Gallery of ... Sadati, is pleased to announce a new treatment option called Vivace Microneedling. This ... face, neck, and body through a virtually pain-free, non-surgical treatment. Vivace Microneedling combines ...
(Date:5/23/2017)... Indianapolis, IN (PRWEB) , ... May 23, 2017 ... ... announced the availability of video chat as a standard feature on its secure ... style from text to voice to video depending on the type and urgency ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... treatment using the SPEED System™ Orthodontics, with or without a referral, from the ... in El Segundo, CA, who is skilled in providing patients with the custom, ...
(Date:5/22/2017)... (PRWEB) , ... May 22, 2017 , ... Patients who ... to receive relaxing sedation dentistry in Mt. Kisco, NY from Advanced Endodontics of Westchester. ... for a variety of treatments. One or more sedation methods may be recommended based ...
(Date:5/22/2017)... ... 2017 , ... “Homeostasis: The Journey of a Manic-Depressive” tells the story in ... Rodriguez takes readers on a rollercoaster ride that includes a midnight trek to the ... a dark place where Donald considers suicide. Readers learn how Donald finally achieves ...
Breaking Medicine News(10 mins):
(Date:5/15/2017)... 2017  Amy Baxter MD, chief executive officer and ... pain relief, was awarded a 2017 Top 40 Healthcare ... recognized at the MM&M Top 40 Healthcare Transformers dinner ... on May 10, 2017. The dinner followed a ... "beyond the pill."  "Innovation goes beyond invention," ...
(Date:5/10/2017)... Mass., May 10, 2017 Hologic, Inc. (Nasdaq: ... results for the fiscal second quarter ended April 1, ... of $1.84 increased 666.7% compared to the prior year ... resulted in a significant gain, while non-GAAP diluted EPS ... 3.2%, or 3.8% in constant currency terms.  Excluding the ...
(Date:5/10/2017)... , May 10, 2017 CSSi, the ... for the clinical research industry, is proud to announce ... . The new website features both enriched content and ... experience and enhances the company,s already well-established position as ... "After many months of hard work, ...
Breaking Medicine Technology: