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Implant Size Articles & Analysis

21 news found

OSSIO Receives Vizient Contract for Bio-Integrative Orthopedic Fixation Technology

OSSIO Receives Vizient Contract for Bio-Integrative Orthopedic Fixation Technology

These products include sterile, disposable instrument kits: OSSIOfiber Hammertoe Fixation System – 10-degree and straight implants in 2.5mm, 2.9mm and 3.2mm sizes. OSSIOfiber Trimmable Fixation Nails – Solid-core in 2.4mm and 4.0mm sizes and cannulated in 3.0mm and 4.0mm sizes. ...

ByOSSIO Inc


Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System

During the minimally invasive transcatheter AccuCinch System procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall. ...

ByAncora Heart, Inc


Exsomed Corporation Announces FDA 510(K) Clearance of the Nanophix Cannulated Lag Screw System for Fracture Fragments

Exsomed Corporation Announces FDA 510(K) Clearance of the Nanophix Cannulated Lag Screw System for Fracture Fragments

Most modern fixation options do not offer the right balance of implant cannulation and sizing, also requiring a complicated surgical technique, which can cause additional comminution to the existing fracture. NanoPhix is the first and only implant to provide a 1.5mm diameter design with cannulation to achieve stable fixation of small fracture ...

ByExsoMed Corporation


EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)

EBR Systems Raises AU$110M in Initial Public Offering on the Australian Securities Exchange (ASX)

In a world-first last year, a team of globally renowned cardiologists from Monash Health used EBR’s WiSE system, in combination with an intracardiac pacemaker, to complete the world’s first implantation of a totally leadless heart pacemaker system in a patient who had not previously had a pacemaker implanted. ...

ByEBR Systems, Inc.


EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors

EBR Systems Appoints Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler to the Board of Directors

Dr Steinhaus has extensive clinical and business experience in cardiac rhythm management, including performing numerous clinical studies in implantable cardiac devices and leads. He is currently the Executive Chairman of the board at Enopace Biomedical Ltd., a company which produces therapeutic neuromodulation devices for the treatment of heart failure and serves as a consultant ...

ByEBR Systems, Inc.


Nalu Medical Named Best MedTech Company and Medical Device in Field of Neurology

Nalu Medical Named Best MedTech Company and Medical Device in Field of Neurology

Nalu Medical is pleased to announce its flagship micro-Implantable Pulse Generator (mIPG™) was selected as the 2021 winner of the MedTech Visionaries Award for Best MedTech Company and Best Medical Device in the field of neurology. ...

ByNalu Medical, Inc.


EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization

EBR Systems’ WiSE CRT System Demonstrates Technical Feasibility of Leadless Left Bundle Branch Area Pacing for Cardiac Resynchronization

Published last month in the European Heart Journal, the case report details the successful deployment of the WiSE Electrode implanted in the LV septum of an 82-year-old male with tachyarrhythmia-induced cardiomyopathy. ...

ByEBR Systems, Inc.


FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

To regulate precise pacing from within the heart, WiSE uses a unique, wireless electrode the size of a grain of rice. It is implanted in the left ventricle wall during a minimally invasive procedure. ...

ByEBR Systems, Inc.


Shoulder Innovations Announces Exclusive License Agreement for Genesis Software Innovations PreView Shoulder Software

Shoulder Innovations Announces Exclusive License Agreement for Genesis Software Innovations PreView Shoulder Software

This team developed a best-in-class product that performs automated segmentation and reconstruction of imaging data, allowing surgeons to have functional visualization of their surgical cases prior to entering the operating room and without needing external data processing. Surgeons can optimize implant size, location and orientation by digitally placing the ...

ByShoulder Innovations


World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Professor Pascal Defaye, Head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System. LBBAP ...

ByEBR Systems, Inc.


Ancora Heart Receives IDE Approval for CorCinch-HF Pivotal Study of the AccuCinch Ventricular Restoration System

Ancora Heart Receives IDE Approval for CorCinch-HF Pivotal Study of the AccuCinch Ventricular Restoration System

During the AccuCinch procedure, an implant is placed into the mid left ventricular wall, the implant is then cinched. Once cinched, the implant is intended to reduce the size of the left ventricle, as well as support and strengthen the heart wall to help improve left ventricular function. ...

ByAncora Heart, Inc


Additive Implants Announces FDA Clearance for SureMAX-X Cervical Spacer

Additive Implants Announces FDA Clearance for SureMAX-X Cervical Spacer

SureMAX®-X offers an industry-leading range of implant sizes; 7º, 10º and 14º lordotic and hyperlordotic angles with footprints of 12 x 14mm, 14 x 16mm, 15 x 18mm, and 15 x 20mm in heights of 5, 6, 7, 8, and 9mm. ...

ByAdditive Implants LLC


Additive Implants Announces FDA Clearance for SureMAX-X Cervical Spacer

Additive Implants Announces FDA Clearance for SureMAX-X Cervical Spacer

SureMAX®-X offers an industry-leading range of implant sizes; 7º, 10º and 14º lordotic and hyperlordotic angles with footprints of 12 x 14mm, 14 x 16mm, 15 x 18mm, and 15 x 20mm in heights of 5, 6, 7, 8, and 9mm. ...

ByAdditive Implants LLC


EBR Systems Closes $30M in New Funding, John McCutcheon Joins Company as President and CEO

EBR Systems Closes $30M in New Funding, John McCutcheon Joins Company as President and CEO

WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart's left ventricle – and the attendant problems – are potentially eliminated. ...

ByEBR Systems, Inc.


EBR Systems Awarded Prestigious Forfait Innovation Package for WiSE CRT System by French Ministry of Social Affairs and Health

EBR Systems Awarded Prestigious Forfait Innovation Package for WiSE CRT System by French Ministry of Social Affairs and Health

The CE Mark-approved WiSE CRT system is the first and only implantable cardiology device to receive this innovation funding in France to date. ...

ByEBR Systems, Inc.


Dr. Mary Norine Walsh Joins SOLVE CRT Clinical Study as Co-Principal Investigator

Dr. Mary Norine Walsh Joins SOLVE CRT Clinical Study as Co-Principal Investigator

WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart's left ventricle – and the attendant problems – are potentially eliminated. ...

ByEBR Systems, Inc.


Bioelectronics startup Neuspera nets $26M in Two-Tranche Series B

Bioelectronics startup Neuspera nets $26M in Two-Tranche Series B

Neuspera is focused on developing techniques to transfer power to implants from outside the body, using electromagnetic waves—to allow for smaller, sealed implant designs, compared to battery-powered neuromodulation devices. ...

ByNeuspera Medical, Inc.


EBR Systems, Inc. Initiates Global Trial of World’s Only Wireless CRT Pacing Technology

EBR Systems, Inc. Initiates Global Trial of World’s Only Wireless CRT Pacing Technology

Rather than using pacing leads — decades-old technology with well-documented problems — WiSE paces the heart via a tiny wireless electrode, the size of a grain of rice, implanted directly in the heart’s left ventricle. ...

ByEBR Systems, Inc.


EBR Systems, Inc. Raises $50 Million to Complete Global Heart Failure Trial

EBR Systems, Inc. Raises $50 Million to Complete Global Heart Failure Trial

Separately, the Company has received European CE Mark approval for its second-generation wireless transmitter and conducted initial cases at four European clinical centers. This major advance is half the size of the first-generation transmitter, extends battery life and enables a simpler and less-invasive implantation procedure. ...

ByEBR Systems, Inc.


Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain disc height and facilitates the formation of a robust fusion column. The V2 Lateral implants, the most recent update to Pinnacle’s patented flagship line of InFill Interbody Fusion Systems, features an ...

ByPinnacle Spine Group

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