As part of the definition of each clinical indication, surgical risk
was categorized qualitatively as "low," "elevated," or "high.
Most patients currently treated in Europe are high surgical risk
A majority of patients had multiple surgical risk
factors, such as advanced age plus medical comorbidities.
These stroke rates in a high surgical risk
population are the lowest to date for CAS and comparable to the peri-procedural rates in the standard surgical risk
CEA arm of CREST (2.
The EVEREST II High Surgical Risk
cohort included data from patients enrolled in the multi-center EVEREST II High Risk and REALISM continued access studies.
In addition, an oral presentation on the use of MitraClip therapy in high surgical risk
patients with MR of degenerative etiology, as well as a number of additional discussions related to the MitraClip system, will take place during the "Valvular Heart Disease Summit: Mitral Valve Therapies" on Tuesday, Nov.
MSHOP will use patient X-rays and analytic morphomics to determine surgical risk
and predict how well patients will do with major surgery.
patients with carotid artery disease are at standard surgical risk
, many of whom require a procedure to open the narrowed arteries that lead to the brain.
But we believe women should not be discouraged from carotid endarterectomy solely on the basis of surgical risk
Unfortunately, the current standard for evaluating these samples cannot be done in real-time and, therefore, often requires a second operation which exposes the patient to additional surgical risk
Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted that, for symptomatic and asymptomatic carotid artery disease patients at standard surgical risk
, there is reasonable assurance that the benefits of the RX ACCULINK(R) Carotid Stent System outweigh its risks (Yes: 7, No: 3, Abstain: 1).
Iwach added, "Implantation of this new technology during cataract surgery offers an ideal opportunity since there should be minimal additional surgical risk
yet tremendous potential benefit.
Abbott will submit the results of a pre-agreed-upon analysis of the CREST data to the FDA in an application seeking an expanded indication for the ACCULINK Carotid Stent System as a treatment option for patients at standard surgical risk
(those patients not considered to be at high risk for surgery).
These pivotal trial results provide important evidence and confidence to physicians that CoreValve is an effective long-term treatment alternative for many patients with severe aortic stenosis who are considered at high surgical risk
or inoperable," said Ulrich Gerckens, M.
Solutions, LLC announced today the introduction of a unique new insurance product designed to provide financial resources to surgical patients in the event that they have adverse outcomes following surgery.