Sorenson Medical Receives FDA Approval To Release ambIT PreSet Pump
Salt Lake City - Sorenson Medical, a provider of pioneering portable ambulatory infusion pumps, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new ambIT PreSet ambulatory infusion pump for management of post-operative pain. The new easy-to-use electronic pain pump simplifies pump programming by allowing the physician to simply select from four preset infusion protocols for delivery of local anesthetic directly to the patient's surgical site. The ambIT PreSet, when used to infuse local anesthetic through a catheter to the wound site, is indicated to reduce pain better than narcotic therapy alone.
Sorenson Medical's pioneering ambIT PreSet pump is on the leading edge of a trend toward lightweight, portable infusion devices that reduce the threat of side effects and addiction from narcotic drugs, while enabling patients to go about their normal lives as they receive pain treatment. Ambulatory pain pumps also allow patients to remain mobile after surgery and to recover comfortably at home, avoiding the risk of hospital-acquired infections and prolonged hospitalization. ambIT PreSet pumps are about the size of a TV remote, are housed in a belt pack and run on two AA batteries.
"The ambIT PreSet pump provides surgeons with a combination of portability, leading-edge technology and ease of use that is unique in the marketplace," said LeVoy Haight, COO of Sorenson Medical. "Sorenson Medical's sophisticated, industry-standard technology delivers medication with extraordinary precision and reliability, but unlike other portable pumps it is extremely easy to use and set up."
The ambIT PreSet pump is designed to simplify programming and minimize pump setup time for surgeons, who don't have time for a lengthy programming process. Setup is as simple as choosing an infusion protocol and selecting the volume of medication the surgeon wants to infuse. In addition to four pre-programmed protocols, the ambIT PreSet pump includes a "set-your-own-protocol" program that allows custom programming. The pump also includes a patient-controlled bolus button for extra doses of relief if the patient feels pain.
To protect the interests of patients, Sorenson Medical offers the PreSet pump through its EASY ACCESS Stock and Bill program, which allows physicians and outpatient surgery centers to stock and use the product at no charge. Sorenson Medical takes responsibility for billing the patient's insurance for the product so that facilities and physicians do not have to.
SOURCE: Sorenson Medical