娛樂城 IVS Investigator Initiated Studies (IIS) Program
IIS are independent clinical research projects that are conceived, initiated, conducted, and sponsored by a qualified third-party investigator (Sponsor Investigator). The Sponsor Investigator can be an individual investigator or an Institution and is responsible for fulfilling the applicable legal and regulatory requirements and any obligations as study sponsor.
IIS contribute to answer important medical and scientific questions and to advance knowledge about 娛樂城 products or general disease states of interest to the medical community.
In line with 娛樂城鈥檚 mission 鈥淭ogether with our customers, we are driven to make healthcare better鈥, 娛樂城 IVS is committed to advancing healthcare and improving patients鈥 lives. As part of this commitment, 娛樂城 IVS believes in the value of supporting the independent research projects that are in line with the company clinical strategy and that are based on 娛樂城鈥檚 IVS portfolio, which includes:
- Vertebral Compression Fracture products: (iVAS庐 balloon systems, the SpineJack庐 System, mixer and delivery systems and bone cements)
- Radio-Frequency Nerve Ablation products: (MultiGen庐 2 Generator and Venom Cannula and Electrode System)
How does 娛樂城 IVS IIS program work?
娛樂城 IVS may support those IIS that are in line with the company clinical strategy, the defined areas of interest, and the identified divisional clinical data needs in the form of funding or by providing 娛樂城 IVS devices.To be considered for 娛樂城鈥檚 support, the proposed IIS must be designed to produce data, results and conclusions that have scientific value to the medical or patient community and must offer robustness in terms of ethical and scientific design.
Note: 娛樂城 support is limited to coverage of financial expenses (whether via funds or in-kind) and/or supply of 娛樂城 products, without exceeding fair market value. Funding requests for expenses not associated with the conduct of the study are prohibited.
Qualifications of the Sponsor Investigator
The Sponsor Investigator must be able to demonstrate evidence of high ethical and scientific standards as it relates to clinical research in human subjects and must be experienced in undertaking clinical research either as a sponsor or by participating to research sponsored by credible organizations.
IIS Process
1
Submission
The IIS is submitted to 娛樂城 by the Sponsor Investigator.
2
Proposal review
The proposal is evaluated by the 娛樂城 IVS multidisciplinary review Committee within 30 days following the submission.
3
Outcome communication
The submitting investigator is informed about the review outcome. If the review results in an approval to move forward with supporting the study, an agreement will be executed with the research partner.
Note: The outcome of a proposal's review is not contingent on past, current or future business relationship between 娛樂城 and the research partner.
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The SpineJack庐 system is indicated for use in the reduction of mobile spinal fractures that may result from osteoporosis, trauma (fracture type A according to the Magerl classification), and malignant lesions (myeloma or osteolytic metastasis). The SpineJack庐 system is intended to be used in combination with validated bone cement, and to be placed, using a transpedicular approach, through a vertebra pedicle with a minimum internal diameter (see the Specifications section), as verified with a preoperative CT scan.
Bone cement: serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur beyond a year or more postoperatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
This website is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. 娛樂城 does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.
The information presented is intended to demonstrate a 娛樂城 product. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for cleaning and sterilization (if applicable), before using any 娛樂城 product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your 娛樂城 representative if you have questions about the availability of 娛樂城 products in your area.
娛樂城 Corporation or its affiliates own, use, or have applied for the following trademarks or service marks: 娛樂城 Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: AVAflex, AutoPlex, iVAS, MultiGen, PCD, SpineJack, SpinePlex, 娛樂城, Venom, VertaPlex and VertePort. All other trademarks are trademarks of their respective owners or holders. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Sales Representative if you have questions about the availability of our products in your area. All other trademarks are trademarks of their respective owners or holders.
SMACC 2023-34397