Here are seven things for spinal surgeons to know for Feb. 28, 2013. Texas Spine & Joint Hospital revealed $27 million expansion.
Texas Spine & Joint Hospital in Tyler has unveiled a $27 million expansion and renovation of its facility. The project included the addition of three pain procedure rooms, admitting offices, pharmacy, laboratory and a surgical pre-operation area. Two new operating rooms are yet to be added to the existing three and renovations are yet to be completed.
FDA 510(k) review times shortened in 2011.
Data analysis from the Emergo Group showed FDA's 510(k) medical device premarket notification review times improved in 2011. The group's data revealed that the rate of 510(k) submissions cleared within three months improved to 42 percent in 2011 from 40 percent in 2010. Average review times also fell to 138 days in 2011 from 146 days in 2010.
Selman Surgery Rehearsal Platform received FDA approval.
The FDA approved Surgical Theater's Selman Surgery Rehearsal Platform, one of the only patented and approved platforms for cerebral and spine pre-surgery rehearsal. The SRP generates 3-D models based on standard scanned images from patients that show the interaction between tissue and surgical instruments.
New spine devices coming.
Zimmer Spine launched its Zimmer DTO 5.5 System for disc degeneration with fusion and non-fusion treatments. The newly released spine implant will build on the success of the original Zimmer DTO System, which connects several other Zimmer devices. Tel Aviv-based Premia Spine developed an implant to treat spinal disorders without fusion.
The TOPS system is designed for motion preservation, unlike fusion which eliminates of the three motion segments, and can be used to treat spondylolisthesis and lumbar spinal stenosis. Premia is conducting clinical trials in the U.S., and it could take five years for FDA approval.
FDA recalled DePuy orthopedic knee device.
The FDA issued a Class 1 recall for DePuy Orthopaedics' LPS Diaphyseal Sleeve, which is used with the LPS system as an end-stage revision knee device. The taper connection between the sleeve and the base may not be able to accommodate the physiologic loads that occur during normal activity. If loads fracture the sleeve at the taper joint, it could lead to loss of function, loss of limb, infection, compromised soft tissue or death.
More Republican governors agree to expand Medicaid.
Gov. Chris Christie (R-N.J) will agree to broaden the eligibility requirements for Medicaid under the Patient Protection and Affordable Care Act in exchange for federal funding, making him the eighth GOP governor to do so. Gov. Christie will announce his support in his budget address this afternoon, following other conservative state leaders like Florida Gov. Rick Scott and Arizona Gov. Jan Brewer.
Nevada Neurosurgery and Sierra Neurosurgery Group merged.
Nevada Neurosurgery, founded by Lali Sekhon, MD, PhD, FACS in 2010, merged with Sierra Neurosurgery Group on February 1. Dr. Sekhon, a spine neurosurgeon with over 20 years of experience, will join with nine neurosurgeons at Sierra Neurosurgery Group, based in Reno, Nev.
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Wenatchee Valley Medical Center Opens New Spine Center
Texas Spine & Joint Hospital in Tyler has unveiled a $27 million expansion and renovation of its facility. The project included the addition of three pain procedure rooms, admitting offices, pharmacy, laboratory and a surgical pre-operation area. Two new operating rooms are yet to be added to the existing three and renovations are yet to be completed.
FDA 510(k) review times shortened in 2011.
Data analysis from the Emergo Group showed FDA's 510(k) medical device premarket notification review times improved in 2011. The group's data revealed that the rate of 510(k) submissions cleared within three months improved to 42 percent in 2011 from 40 percent in 2010. Average review times also fell to 138 days in 2011 from 146 days in 2010.
Selman Surgery Rehearsal Platform received FDA approval.
The FDA approved Surgical Theater's Selman Surgery Rehearsal Platform, one of the only patented and approved platforms for cerebral and spine pre-surgery rehearsal. The SRP generates 3-D models based on standard scanned images from patients that show the interaction between tissue and surgical instruments.
New spine devices coming.
Zimmer Spine launched its Zimmer DTO 5.5 System for disc degeneration with fusion and non-fusion treatments. The newly released spine implant will build on the success of the original Zimmer DTO System, which connects several other Zimmer devices. Tel Aviv-based Premia Spine developed an implant to treat spinal disorders without fusion.
The TOPS system is designed for motion preservation, unlike fusion which eliminates of the three motion segments, and can be used to treat spondylolisthesis and lumbar spinal stenosis. Premia is conducting clinical trials in the U.S., and it could take five years for FDA approval.
FDA recalled DePuy orthopedic knee device.
The FDA issued a Class 1 recall for DePuy Orthopaedics' LPS Diaphyseal Sleeve, which is used with the LPS system as an end-stage revision knee device. The taper connection between the sleeve and the base may not be able to accommodate the physiologic loads that occur during normal activity. If loads fracture the sleeve at the taper joint, it could lead to loss of function, loss of limb, infection, compromised soft tissue or death.
More Republican governors agree to expand Medicaid.
Gov. Chris Christie (R-N.J) will agree to broaden the eligibility requirements for Medicaid under the Patient Protection and Affordable Care Act in exchange for federal funding, making him the eighth GOP governor to do so. Gov. Christie will announce his support in his budget address this afternoon, following other conservative state leaders like Florida Gov. Rick Scott and Arizona Gov. Jan Brewer.
Nevada Neurosurgery and Sierra Neurosurgery Group merged.
Nevada Neurosurgery, founded by Lali Sekhon, MD, PhD, FACS in 2010, merged with Sierra Neurosurgery Group on February 1. Dr. Sekhon, a spine neurosurgeon with over 20 years of experience, will join with nine neurosurgeons at Sierra Neurosurgery Group, based in Reno, Nev.
More Articles on Spine:
Vertebral Motion Analysis Comes to Allegheny General Hospital
5 Achievable Goals for Spine Practice Operational Success
Wenatchee Valley Medical Center Opens New Spine Center