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December 19th – December 25th

December 20th: Atrium Medical Receives FDA Approval for its ClearWay(TM) RX Therapeutic Perfusion Catheter

Atrium Medical Corporation announced today that it has received US FDA 510(k) marketing clearance for a new small vessel therapeutic perfusion catheter called ClearWay(TM) RX. ClearWay RX is indicated for localized delivery of therapeutic agents to the coronary and peripheral vasculature.

ClearWay(TM) RX is the world's first Rapid Exchange therapeutic perfusion catheter for localized therapeutic delivery within small caliber vessels. Delivering a smaller quantity of a preferred therapeutic agent locally has been shown to help reduce systemic effects. ClearWay RX is a low pressure perfusion catheter which incorporates a thin, semi-compliant microporous PTFE balloon material to deliver small quantities of medication. This patented microporous balloon allows for controlled infusion at very low pressures (2 - 4atm) for maximum local therapeutic effect at a discrete targeted location. The rapid exchange perfusion catheter is .014" guidewire compatible, allowing access to several difficult to reach target destinations throughout the body. ClearWay RX is available in 1.0 to 4.0 mm balloon diameters and in balloon lengths ranging from 10 to 50 mm. Longer balloon lengths provide for a wide range of local tissue treatment options with a single therapeutic perfusion inflation.

ClearWay RX is the latest advance in a series of unique medical device innovations, built on a 25 year heritage of excellence in advanced polymer and biomaterial science at Atrium. This late breaking interventional drug delivery technology creates a novel approach for several promising new pharmaceutical agents which may prove beneficial with more localized delivery with far less systemic payloads.

Atrium Medical Corporation of Hudson, New Hampshire, celebrating 25 years of cardiovascular healthcare innovation manufactures over two million sterile medical devices each year which are distributed worldwide. Atrium's vast expertise in developing medical device technologies for the treatment of heart and vascular disease has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery, hernia and soft tissue repair.

December 20th: Ascent Healthcare Receives 510(k) Clearance on Carter-Thomason CloseSure(R) System

Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the U.S. Food and Drug Administration (FDA) has cleared Ascent's 510(k) to reprocess the Inlet Carter-Thomason CloseSure® System model #CTI-512N. The cleared 510(k) covers all three components of the system: a 5 mm and a 10/12 mm Pilot® suture passer guide and the Carter-Thomason® suture passer. Ascent is the only reprocessor to receive a 510(k) clearance for this system.

The system, which offers an alternative to hand suturing, is designed to ensure complete trocar wound closure after laparoscopic surgery and to prevent post-surgical herniation in obese patients, a common problem. Complications caused by hand suturing can increase risk to patients by prolonging procedures and time spent under anesthesia. The Inlet Carter-Thomason CloseSure System is the only device that provides full-thickness suturing of all port sites.

Using Carter-Thomason CloseSure Systems reprocessed by Ascent will save a mid-sized hospital (about 250 beds) approximately $18,000 a year - about $50 per device. Additionally, each hospital that uses these devices will eliminate approximately 100 pounds of medical waste annually.

Carter-Thomason CloseSure Systems reprocessed by Ascent are rinsed, soaked, brushed and sonicated in disinfectant to remove contaminants located on the outside of the device. The devices are then attached to a specially designed manifold that flushes the inner lumens with cleaning solution. As part of functional testing, each suture passer undergoes an actuation test to ensure the device tip opens and closes smoothly. All devices are sterilized using 100 percent ethylene oxide to an assurance level of 10(-6). Residuals do not exceed recommended limits of ISO 10993-7.

Ascent Healthcare Solutions and its predecessor companies have safely reprocessed more than 50 million single-use devices for over 1,700 healthcare facilities nationwide, including most of the U.S. News and World Report "Honor Roll" hospitals. In 2006, the company will save hospitals more than $90 million in supply expenses and eliminate more than 7,000 tons from U.S. landfills.

December 21st: Natus Medical Receives FDA Approval for the Olympic Cool-Cap

Natus Medical Incorporated today announced that it has received premarket approval ("PMA") from the Food & Drug Administration ("FDA") to market its Olympic Cool-Cap, a Class III medical device. The Cool-Cap system, which is the only FDA-approved device for the treatment of hypoxic ischemic encephalopathy ("HIE") in term newborns, provides selective head cooling to prevent or reduce the severity of neurologic injury associated with HIE.

Approximately three in 1,000 newborns are at risk of brain injury due to an interruption of blood flow and oxygen supply during labor and delivery. In 1999, Olympic Medical initiated a four-year international multi center study of the Cool-Cap system. Results of the study confirmed that when head cooling therapy was administered to patients within the first six hours of life, thereby lowering the body temperature three to four degrees Centigrade, the severity of brain injury was significantly decreased compared to the untreated control group. The study enrolled babies at high risk for moderate to severe brain injury as diagnosed by using the Company's Olympic CFM 6000 Cerebral Function Monitor, which aids in identifying neurological abnormalities such as HIE.

Natus plans to market the Cool-Cap system to Level III neonatal intensive care departments ("NICU's") worldwide, with each center utilizing two Cool-Cap devices. Based on these metrics, Natus anticipates a market potential of over 4,000 devices worldwide. Natus expects that NICU's in regional centers of excellence will become the first adopters of the treatment and that head cooling therapy will quickly become a standard of care for the treatment of newborn HIE.

Olympic Medical, which was acquired by Natus in October 2006, developed the CFM 6000 Cerebral Function Monitor and received FDA 510(k) clearance to market the product in 2003. The CFM 6000 is used in the Neonatal Intensive Care Unit and other acute care departments to perform continuous, long-term monitoring of a newborn's brain activity. The CFM 6000 monitor enables clinical staff to assess the function of the brain as an aid to both diagnosis and treatment of a variety of neurological conditions such as seizures, HIE, and the effects of medication. The Olympic CFM 6000 utilizes an FDA-cleared single-channel amplitude-integrated EEG algorithm for cerebral function monitoring that is the basis for most clinical studies published on the subject since 1975. The FDA treatment protocol for the Cool-Cap system requires an assessment made with the Olympic CFM 6000 to select patients for treatment.

Natus is a leading provider of healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical ailments such as hearing impairment, neurological dysfunction, epilepsy, sleep disorders, newborn jaundice, and newborn metabolic testing.

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