camber spine technologies announces 510(K) clearance for their Siconus™ si Joint Fixation system
WAYNE, Pa., January 23, 2017 –
Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconus™ SI Joint Fixation System. Siconus™ becomes the second product in the Camber Spine Technologies portfolio to treat sacroiliac disease, as a complement to the Prolix™ custom machined allograft implant.
“The Siconus™ SI Fusion Screw System is an important addition to our growing portfolio of devices and completes our exclusive SI Fusion product portfolio.” said Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies. “Siconus™ provides superior compression across the SI Joint over multiple turns of the threaded fixation implants. When used with the Prolix™ SI Joint Fusion System, the combined solution offers a direct visualization and insertion of a machined allograft spacer into the SI joint, followed by a lateral approach compression and fixation implants. The combined solution may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint. “
The Siconus™ SI Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.
Siconus™ was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company.
CAMBER SPINE TECHNOLOGIES PRESENTS:
SURGICAL INNOVATION CADAVER LAB AT NASS BOSTON
Join us at NASS for a Surgical Innovation Cadaver Lab presentation of two of the most cutting-edge products in spine surgery today ENZA™ MIS Zero Profile ALIF & PROLIX™ SI Fusion System.
Thursday, October 27th from 2-4pm
The Learning Place
Boston Convention and Exhibition Center
Registration limited to 35 surgeons
For more information or to register please contact Patricia Deeney email@example.com
Visit us at NASS Boston October 26th-28th booth #1808 to see our full range of spinal implants.
CAMBER SPINE TECHNOLOGIES REVOLUTIONIZES SACROILIAC SURGERY WITH
PROLIX™SACROILIAC JOINT FUSION SYSTEM
WAYNE, PA, August 5, 2016
Camber Spine Technologies has partnered with Dr. Joseph DiCicco of Orthopedic Associates of Southwestern Ohio to conduct a post-operative pain study on patients receiving the Prolix™ implant. Patients in the study have undergone pain management therapy for sacroiliac pain over an extended period of time and have now opted for surgical treatment of the sacroiliac joint. The study will compare patient pain scores pre- and post-operatively.
“The recent release of Camber’s Prolix™ has resulted in the first real advancement in SI Fusion surgery options in years. As the first bone graft delivery system to complement the ‘old school screws only’ fix of the past, Prolix has revolutionized this difficult diagnosis. This percutaneous procedure has been well received by my patients, with some saying you’ve changed my life forever, no longer do I need pain pills or even to see my pain management physician! In sacroiliac disease, as the surgeon, it’s all about patient selection. A perfect sacroiliac surgery candidate is one who had excellent initial relief from SI fluoroscopic injection but who slowly, over time, no longer experienced such relief from injection therapy. When I suggest a percutaneous, outpatient surgery to correct a commonly debilitating diagnosis, it often brings tears to my patients’ eyes. Just the option to get long-term relief is a new hope for many of them. I am very pleased with the results so far and will continue to offer this as a permanent fix for my patients!”
- Joe DiCicco, DO
Prolix™ Sacroiliac (SI) Joint Fusion System, by Camber Spine Technologies, is a true fusion of the SI joint through a direct visualization, minimally invasive approach. The Prolix™ SI Joint Fusion System is used to treat degenerative sacroiliitis and SI joint disruptions in skeletally mature patients. Prolix™ is a two-step minimally invasive procedure which consists of the implantation of a custom machined allograft implant through direct visualization and a supplemental “lateral fixation of the SI Joint” using supplemental bone screws.
CAMBER SPINE TECHNOLOGIES ANNOUNCES FIRST IMPLANTATION OF
ENZA™ ZERO-PROFILE ALIF DEVICE
WAYNE, PA, July 05, 2016
Camber Spine Technologies, today announced the first implantation of the ENZA™ MIS Zero-Profile Anterior Lumbar Interbody Fusion (ALIF) device in a two-level lumbar procedure at levels L4/L5 and L5/S1 at Kennedy University Hospital, Washington Township, by Dr. Jeffrey Gleimer, D.O. ENZA™ is the company’s first device launched with integrated fixation to promote minimally invasive mechanical fusion.
“Today I implanted the ENZA ALIF device in a patient to replace two damaged discs. The brilliant design of the implant has perfected true direct midline fixation within the retroperitoneal space for lumbar fusion. The ENZA ALIF device far surpasses its competitors in providing a simple, easy to implant device with superior osseous fixation, even in significantly sclerotic bone, while also significantly reducing my operative time. I’m excited to be a part of the team bringing this device to the market and looking forward to improved patient outcomes across the country and hopefully the world!”
-Dr. Jeffrey Gleimer, D.O.
The Camber Spine Technologies ENZA™ MIS Zero-Profile ALIF device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These implants may be implanted via laparascopic or an open anterior approach. The Camber Spine Technologies’ ENZA™ MIS Zero-Profile ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.
Camber Spine Technologies Receives FDA Clearance for ENZA™ Zero Profile ALIF Device:
510(k) Clearance Marks Camber’s Eighth Spinal Product Line to Market
WAYNE, PA, May 5, 2016
Camber Spine Technologies announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZA™ Zero Profile Anterior Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation. This clearance marks Camber’s eighth line of spinal implant systems to be released in the US market. The ENZA™ Zero Profile ALIF system is intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The system is intended for use with bone graft and with supplemental fixation systems. The ENZA™ bladed stabilization system, utilizes a simple, one step insertion and fixation method through a minimally invasive approach to achieve interbody fusion.
"We are pleased to receive 510(k) clearance for the Enza system, the latest addition to Camber's product offerings in spine stabilization. This important milestone marks the beginning of a year in which we hope to launch several differentiated technologies and continue to expand our presence to new geographies. Camber's mission is to deliver surgeon inspired technologies to the patient."
-Daniel A. Pontecorvo, CEO Camber Spine Technologies
The ENZA™ product was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company enabling medical device companies to expedite the commercialization of their technologies.
CAMBER SPINE TECHNOLOGIES LAUNCHES TWO NEW PRODUCTS:
2016 Commercial Product Launches
Wayne, PA, April 26, 2016
Camber Spine Technologies is proud to announce the launch of PROLIX™ and ORTHROS MIS™
The PROLIX™ SI Fusion System provides a safe, minimally invasive approach for what Camber believes is the first true fusion product designed to treat Sacro-Iliac pain. The system utilizes an safe inferior approach between the Posterior Superior Iliac Spine (PSIS) and the Posterior Inferior Iliac Spine (PIIS). A machined cortical bone spacer is implanted between the sacrum and ilium through a special cannula. The space is now treated like a discectomy to help promote fusion as opposed to only limiting motion of the joint when solely using lateral screws. PROLIX™ used in conjunction with lateral screws has the potential to decrease the opportunity for revisions by providing a true fusion technique to the spinal implant market to treat Sacro-Iliac pain. Cases are currently being performed so contact Camber Spine to see how you can use PROLIX™ in your hospital or practice.
The ORTHROS MIS™ Posterior Stabilization System is the latest addition to Camber’s high performing ORTHROS™ brand pedicle screws. The MIS version of the system includes breakaway screw head extensions which facilitate the MIS technique. The pedicle screws are designed to provide rod reduction within the screw head. An effective instrument combination for compression and distraction enables the surgeon to adjust the spinal segments instead of toggling polyaxial screw heads. The Rod Inserters are some of the most rigid and small stature Inserters on the market which further facilitate an MIS technique. The system provides a flexibility unlike any other to promote the different techniques used for MIS surgery. There are (4) different Dilation options which can reduce the number of steps used to implant each pedicle screw. Neuro-monitoring is easily performed through the PEEK Dilators and Tap Sleeve.