Maquet lands FDA nod for Air-Band catheter device

April 11, 2013 By Brad Perriello Leave a Comment

Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular racked up a win for another of its devices designed to close artery incisions for catheters after the FDA cleared its Air-Band radial compression device for the U.S. market.

The device is designed to help seal the radial artery after a catheterization procedure, in which the catheter is threaded into the heart via a radial artery incision in the wrist.

"Drawing on our significant experience in hemostasis management, we designed Air-Band to provide all the valued benefits of our Safeguard pressure-assisted device – which assists in obtaining and maintaining hemostasis after a femoral procedure – and applied our knowledge to a radial application," Maquet Cardiovascular president & CEO Christian Keller said in prepared remarks. "Both devices simplify hemostasis management by delivering hands-free adjustable pressure, offering simple application and removal, and providing clear site visibility and assessment without compromising patient comfort, which is a priority for us."

Last month Maquet won 510(k) clearance and CE Mark approval in the European Union for a new, larger-volume version of its Sensation Plus intra-aortic balloon catheter.

Plastikos implements bio-contamination testing and compliance under ISO 14698
Plastikos (Erie, Pa.) recently announced that it has implemented a formal bio-contamination testing and compliance system that’s in full compliance with ISO 14698-1 and ISO 14698-2 — a move the company described as paramount amid the COVID-19 pandemic. Plastikos and Plastikos Medical presently mold medical devices and parts within multiple ISO-7 certified cleanrooms. The new… […]
How 3D printing is enabling ventilator splitting
Amid the shortage of ventilators due to the COVID-19 pandemic, researchers are finding success using 3D printing to enable “ventilator splitting.” The search continues to go on for more machines, but there have already been government actions taken to increase amounts, while researchers have taken it into their own hands to create homemade-style ventilators. However,… […]
How R&D departments are coping with coronavirus
Hardly anyone’s R&D workplace has been spared all the repercussions of the COVID-19 crisis. People are working remotely, staggering their hours in laboratories to avoid too many coworkers, and relying heavily on conference calls and video meetings. Our WTWH Media sister site R&D World spoke to a few industry people to see how they’re coping… […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. “In this emergency,… […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency when… […]
BARDA opens research portal to fight COVID-19
By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into… […]
Group seeks manufacturers’ input to reduce medical supply shortages
The National Center for Manufacturing Sciences (NCMS) today announced a new partnership with the U.S. Department of Defense (DOD) and the Federal Emergency Management Agency (FEMA) to reduce the critical shortage of medical equipment and supplies due to the coronavirus pandemic. The industry organization said it is seeking feedback from advanced manufacturing companies about capability,… […]
What is medical tubing used for?
Medical tubing is designed for a number of applications that allow clinicians to administer fluid and devices or allow for gas flow. Common applications of medical tubing include ventilators and IVs, but tubing also finds uses supporting access devices and as a delivery method for other devices. For example, tubing can be used to drive […]
Hack the Crisis: Clippard expects growth as it increases production for ventilator pneumatics
Mary Gannon, Fluid Power World Cincinnati-based Clippard said today it expects to hire more staff to meet the growing demand for its components and subassemblies for ventilators, diagnostic equipment and other critical care devices to help fight the coronavirus. The company manufactures valves, electronic pressure controls, custom assemblies, cylinders, air-preparation equipment and fittings for hose… […]
EPA inspector general wants more public input on ethylene oxide exposure
The U.S. Environmental Protection Agency’s inspector general this week recommended opening a channel of communication between government officials and people who live near 25 plants that use ethylene oxide (EtO), including eight used for sterilizing medical devices. But EPA administrator Andrew Wheeler objected, publicly indicating that his office was blindsided by the request. The forum… […]
Don’t curb your enthusiasm, but be realistic about MacGyver ventilators
In a coronavirus pandemic in which patients on the best commercial ventilators will die, are garage enthusiasts ready to stand behind their work? Scott Thielman, Product Creation Studio Almost a decade ago, Dr. Robert Clark, a pulmonologist then at Regional Hospital for Respiratory and Complex Care near Seattle, approached my company with a warning and an… […]