Archive for July, 2009

Shipment of Alaris infusion pumps resumed

CardinalCardinal Health Inc has received FDA clearance to resume shipments of its flagship line of infusion pumps after problems triggered a halt to shipping earlier this year. The company had put the shipping of the patient-controlled modules for the pumps, which allow a patient to press a button for pain medication, on hold in March. It would now immediately resume customer implementations of its Alaris(R) PC units and PCA (Patient Controlled Analgesia) modules.

HyperBranch recieves CE Mark for NuSeal 100

HyperBranch Medical Technology Inc has received a CE Mark for its NuSeal 100 dural sealant product. NuSeal 100 is used in cranial neurosurgical procedures where a water tight seal is required on the dura. NuSeal 100 is intended for direct application on the dural surfaces to provide a positive seal after suturing thereby minimizing risks associated with post-surgical CSF leaks.

BOSS submitted for the FDA approval

Bovie Medical Corp has applied for pre-market clearance from the FDA for a device designed to be used in orthopedic surgeries. The device, named BOSS, primarily will be targeted toward orthopedic hip and knee reconstruction surgeries. More than 1.3 million such procedures are performed in the US annually and the market is growing due to a move active and aging population.

Study depicts 98.8% survival rate through laparoscopy-assisted surgery

A study published in the June 2009 issue of the Archives of Surgery depicted that laparoscopy-assisted surgery for early gastric cancer resulted in a 98.8% three-year overall survival rate in patients with early gastric cancer. Laparoscopic gastrectomy is a minimally invasive surgical procedure, in contrast with the total removal of the lymph nodes in traditional treatment. In Laparoscopic gastrectomy, a surgeon removes the stomach through a lighted tube, eliminating the need for large surgical incisions and possibly reducing the risk of infection, healing complications, pain and blood loss.

FDA Okays Bryan Cervical Disc

The US Food and Drug Administration (FDA) has approved a novel artificial cervical disc, BRYAN, for the treatment of single-level cervical disc diseases like radiculopathy and/or myelopathy. The titanium-polyurethane disc, developed by Medtronic Inc, is implanted in milled pockets of adjacent vertebral bodies from C3-C7 to substitute a diseased or bulging natural cervical disc.