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Implant Results Articles & Analysis

16 news found

Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

William Welch, MD of the University of Pennsylvania and co-principal investigator of the LimiFlexIDE study added, "I am encouraged by the clinical outcomes and results we have seen so far in the study. LimiFlex is an exciting new possibility for patients currently undergoing fusion for degenerative spondylolisthesis and would offer much faster recovery for patients, significant ...

ByEmpirical Spine, Inc.


Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

The trial has reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial; the control arm will continue enrolling subjects to its target of 160 patients. The results of the LimiFlex trial will form the basis for a PMA application to the U.S. ...

ByEmpirical Spine, Inc.


Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

To date, a total of 168 study subjects have reached 12 months follow up. The results of the LimiFlex trial will form the basis for a PMA application to the U.S. ...

ByEmpirical Spine, Inc.


FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion

FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion

LimiFlex received the CE Mark in 2009 and has been implanted with excellent results in more than 2,000 European patients. Results to date, including this 10-year experience, show the potential for LimiFlex to provide a robust, motion-preserving, minimally invasive, outpatient solution. ...

ByEmpirical Spine, Inc.


Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

LimiFlex received the CE Mark in 2009 and has been implanted with excellent results in more than 2,000 European patients. Results to date, including this 10-year experience, show the potential for LimiFlex to provide a robust, motion-preserving, minimally invasive, outpatient solution. ...

ByEmpirical Spine, Inc.


PolyActiva to Present Positive Clinical Trial Results at the 2022 American Glaucoma Society Annual Meeting

PolyActiva to Present Positive Clinical Trial Results at the 2022 American Glaucoma Society Annual Meeting

The accepted poster, “Interim Phase 2a Clinical Study Results with PA5108 Latanoprost Ocular Implant for the Treatment of Glaucoma” will be presented by Associate Professor Michael Coote, MD, a leading glaucoma specialist at Melbourne Eye Specialists and a principal investigator of the study. ...

ByPolyActiva Pty Ltd.


Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

LimiFlex received the CE mark in 2009 and has been implanted with excellent results in more than 2,000 European patients. Results to date, including 10-years' experience with the device in Europe, show the potential for LimiFlex to provide a robust, motion-preserving, minimally invasive, outpatient solution for this large patient population. ...

ByEmpirical Spine, Inc.


Nevro Announces FDA Approval for Expanded Labeling for its 10 kHz High Frequency Spinal Cord Stimulation System for Treatment of Non-Surgical Refractory Back Pain (NSRBP)

Nevro Announces FDA Approval for Expanded Labeling for its 10 kHz High Frequency Spinal Cord Stimulation System for Treatment of Non-Surgical Refractory Back Pain (NSRBP)

REDWOOD CITY, Calif., Jan. 19, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced receipt of FDA approval for expanded labeling for its Senza® Spinal Cord Stimulation (SCS) System for the treatment of Non-Surgical Refractory Back Pain (NSRBP). This approval ...

ByNevro Corp.


Clinical Data Presented at 2022 North American Neuromodulation Society (NANS) Annual Meeting Reinforce Significant and Durable Benefits of Nevro`s 10 kHz Therapy

Clinical Data Presented at 2022 North American Neuromodulation Society (NANS) Annual Meeting Reinforce Significant and Durable Benefits of Nevro`s 10 kHz Therapy

SENZA-PDN Randomized Controlled Trial Results Demonstrate Significant and Sustained Outcomes with 10 kHz Therapy at 18-Months Follow-Up. SENZA-NSRBP Randomized Controlled Trial Results Show Profound Improvements in Non-Surgical Refractory Back Pain Patients Receiving 10 kHz Therapy Relative to Conventional Medical Management at 12-Months Follow-Up. Both SENZA-PDN and SENZA-NSRBP Studies ...

ByNevro Corp.


Active Implants’ NUsurface Meniscus Implant Provides Statistically Superior Pain Relief

Active Implants’ NUsurface Meniscus Implant Provides Statistically Superior Pain Relief

Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced two-year results of the MERCURY study, which showed that the company’s NUsurface® Meniscus Implant provides statistically superior pain relief beginning at six months compared to non-surgical therapy. ...

ByActive Implants LLC


Empirical Spine Closes $10 Million Series B Financing

Empirical Spine Closes $10 Million Series B Financing

"As study data accumulates, we have more and more evidence that LimiFlex is on track to meet or exceed the clinical results we hoped for. The new funds will enable us to develop and submit a very strong PMA filing in the coming months." ...

ByEmpirical Spine, Inc.


Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

The Alleviant System is a novel transcatheter device for the creation of a therapeutic interatrial shunt without a permanent cardiac implant. Results were presented at the American College of Cardiology Scientific Session (ACC.21) and at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) by Colin Barker, MD, ...

ByAlleviant Medical, Inc.


A new type of corneal availability

A new type of corneal availability

It is made of an optically clear, foldable, biocompatible co-polymer with the mechanical strength to allow smooth and controlled insertion and easy intraocular manipulation – without the risk of damaging the implant (a potential issue with donor tissue). The end result: a strong, resilient graft that covers around 40 percent of the cornea’s area, ...

ByEyeYon Medical Ltd


Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System

Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System

Initial post-implantation results from these patients, who received a 24mm valve, show favorable low aortic valve pressure gradients and no observed paravalvular leakage or aortic insufficiency. The Colibri TAVI System is being developed with 21mm, 24mm, 27mm and 30mm valves to accommodate a variety of clinical and patient needs. Thirty-day follow-up ...

ByColibri Heart Valve LLC


Graftys Announces Creation of an International Implant Registry to Follow up Graftys® HBS and Graftys® QuickSet

Graftys Announces Creation of an International Implant Registry to Follow up Graftys® HBS and Graftys® QuickSet

Aix-en-Provence, November 16th, 2015 – GRAFTYS SA, a company which develops and commercializes biomaterials used in orthopedic surgery, announces that it has recently established an ambitious Post Marketing Surveillance program, in the form of an internationally based registry of patients who have received implants of GRAFTYS® HBS and GRAFTYS® QuickSet. Both of ...

ByGraftys


Imperial Innovations Launches Orthonika

Imperial Innovations Launches Orthonika

” TONY HICKSON, MANAGING DIRECTOR TECHNOLOGY TRANSFER AT IMPERIAL INNOVATIONS, SAID: “The science developed at Imperial is at the very forefront of orthopaedic implant technology and the result of thorough study and experimentation. ...

ByOrthonika

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