FDAnews Device Daily Bulletin

SORENSON RECEIVES FDA APPROVAL FOR AMBIT PRESET PUMP

March 29, 2006
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Sorenson Medical, a provider of portable ambulatory infusion pumps, announced that it has received 510(k) clearance from the FDA for its ambIT PreSet ambulatory infusion pump for managing post-operative pain.

The electronic pain pump simplifies the programming by allowing the physician to select from four preset infusion protocols for delivering 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, according to Sorenson Medical.

Ambulatory pain pumps allow patients to remain mobile after surgery and to recover 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.