Cerapedics launches P-15L peptide-enhanced bone graft IDE trial

Cerapedics said today it launched a new investigational device exemption trial looking to explore the safety and efficacy of its next-gen P-15L peptide enhanced bone graft in transforaminal interbody fusion surgeries. The Westminster, Colo.-based company said it has enrolled the first patients in the study, which aims to enroll a total of 364 patients with degenerative disk disease at 30 sites across the US. “We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures. More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery. Our first-generation bone graft is already approved for anterior cervical discectomy and fusion procedures, and this pivotal study in TLIF procedures will be instrumental in a second premarket approval application for our next-generation P-15 technology in the years ahead,” CEO Glen Kashuba said in a press release. The trial will compare the company’s P-15L enhanced bone graft against an autologous bone graft during TLIF surgery, Cerapedics said. The P-15L bone graft is based on biomimetic small peptide tech intended to support bone growth through cell attraction, attachment and activation. “This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators. We are grateful for all of the efforts that have gotten us to this poi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Orthopedics Cerapedics Inc. Source Type: news

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Authors: Gajski D, Dennis AR, Arnautovic KI Abstract Anterior cervical discectomy and fusion (ACDF) is one of the most common spinal procedures, frequently used for the treatment of cervical spine degenerative diseases. It was first described in 1958. Interestingly, to our knowledge, 3-level ACDF has not been previously published as a peer-reviewed video case with a detailed description of intraoperative microsurgical anatomy. In this video, we present the case of a 33-year-old male who presented with a combination of myelopathy (hyperreflexia and long tract signs in the upper and lower extremities) and bilateral r...
Source: Bosnian Journal of Basic Medical Sciences - Category: General Medicine Tags: Bosn J Basic Med Sci Source Type: research
Conclusion. While the radiographic nonunion rate at 24 months was 13%, PROs show that many of the radiographic nonunions were asymptomatic. Although the majority of patients with radiographic nonunion did not undergo additional surgery, the rate of secondary surgeries at the index level was significantly higher in the radiographic nonunion group. Level of Evidence: 2
Source: Spine - Category: Orthopaedics Tags: CERVICAL SPINE Source Type: research
Abstract OBJECTIVE: A consequence of anterior cervical discectomy and fusion (ACDF) is graft subsidence, potentially leading to kyphosis, nonunion, foraminal stenosis, and recurrent pain. Bone density, as measured in Hounsfield units (HUs) on CT, may be associated with subsidence. The authors evaluated the association between HUs and subsidence rates after ACDF. METHODS: A retrospective study of patients treated with single-level ACDF at the University of California, San Francisco, from 2008 to 2017 was performed. HU values were measured according to previously published methods. Only patients with preoperati...
Source: Journal of Neurosurgery.Spine - Category: Neurosurgery Authors: Tags: J Neurosurg Spine Source Type: research
Conclusions: For one-level ACDF, the anchored cage with screws has some advantage compared to the stand-alone PEEK cage in avoiding dysphagia and restoring disc space height and cervical lordosis. We suggest the anchored spacer may be a good substitute for the stand-alone cage in one-level ACDF. Level of Evidence: Level II
Source: Current Orthopaedic Practice - Category: Orthopaedics Tags: Original Research Source Type: research
AbstractRecently, a bioactive glass ceramic (BGC) has been developed for use as intervertebral cages for anterior cervical discectomy and fusion (ACDF). However, the effectiveness and safety of BGC cages remain to be evaluated. We completed a retrospective comparison of the radiological and clinical outcomes of 36 patients (52 levels) who underwent ACDF with a BGC cage and 35 patients (54 levels) using allograft bone. The following variables were compared between the two groups: the visual analog (VAS) neck and arm pain score and the neck disability index (NDI), measured before surgery and 1  year after; the change in...
Source: Neurosurgical Review - Category: Neurosurgery Source Type: research
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
CONCLUSIONS FE analysis identified the optimal cervical intervertebral cage design for ACPC fixation of C5-C6. This method may be useful for future developments in the design of spinal implants. PMID: 31697650 [PubMed - in process]
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
CONCLUSIONS: Using local bone dust as cage filling material resulted in fusion rates similar to those for an iliac bone graft, while avoiding potential complications and pain caused by iliac bone harvesting. A higher rate of extragraft bone bridge formation was achieved by implanting local bone dust outside the cage. PMID: 31174186 [PubMed - as supplied by publisher]
Source: Journal of Neurosurgery.Spine - Category: Neurosurgery Authors: Tags: J Neurosurg Spine Source Type: research
Conclusions: A significant proportion of patients with degenerative cervical disc disease show remarkable recovery after ACDF.
Source: Journal of Craniovertebral Junction and Spine - Category: Orthopaedics Authors: Source Type: research
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