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Implant Results Articles & Analysis

31 news found

Why is it essential to control VOCs in IVF clinics and fertility labs?

Why is it essential to control VOCs in IVF clinics and fertility labs?

Their presence in the incubator air or the laboratory environment can cause cellular stress, damage DNA, halt embryonic development or affect its viability, resulting in implantation failure and, ultimately, treatment failure. For this reason, continuous monitoring of VOCs in assisted reproduction clinics is no longer an option but a necessity. ...

ByEnvira


Puzzle Medical Devices Inc. Wins TCT 2022 Shark Tank Innovation Competition

Puzzle Medical Devices Inc. Wins TCT 2022 Shark Tank Innovation Competition

The Cardiovascular Research Foundation (CRF) is pleased to announce that Puzzle Medical Devices Inc. has won the TCT 2022 Shark Tank Innovation Competition for its novel circulatory support device that is implanted percutaneously in the abdominal aorta. The competition took place during Transcatheter Cardiovascular Therapeutics (TCT), the world’s premier educational meeting ...

ByPuzzle Medical Devices Inc.


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.


Neuspera Announces Second Phase of Sans-UUI IDE Clinical Trial with Nuvella System

Neuspera Announces Second Phase of Sans-UUI IDE Clinical Trial with Nuvella System

“The Nuvella system is the smallest available SNM device designed to minimize post-procedure discomfort and have no visible external appearance of the implant.” The feasibility phase results of SANS-UUI were presented at the annual meeting of the American Urological Association (AUA) in September 2021 and at the winter meeting of the Society of ...

ByNeuspera Medical, Inc.


iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials

iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials

MINIject® is the only commercially available supraciliary minimally invasive glaucoma surgery (MIGS) device. The two-year results indicated sustained, meaningful efficacy and favourable safety outcomes in patients with primary open-angle glaucoma. ...

ByiSTAR Medical SA


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.


Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode for Severe Paralysis

Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode for Severe Paralysis

Four Patients With ALS Who Received Stentrode™ Implant Gained Ability to Perform Daily Online Tasks No Serious Adverse Events Reported after 12 Months Synchron, a brain computer interface (BCI) company, today announced the results from a study in which four people with ALS received an implant of Synchron’s ...

BySynchron, Inc.


Centennial Hills Hospital Medical Center is the First Hospital in the Western United States to Perform a Total Knee Replacement Procedure with THINK Surgical’s Leading Robot System

Centennial Hills Hospital Medical Center is the First Hospital in the Western United States to Perform a Total Knee Replacement Procedure with THINK Surgical’s Leading Robot System

The system, manufactured by the Fremont, CA – based company features a true, active robot which supports a choice of knee implants from multiple manufacturers in its open implant library. The TSolution One® System from THINK Surgical is the only surgical robot for TKA that allows choice across a library of implants from different ...

ByThink Surgical 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.


Aprevent VOIS received German NUB approval for the second year in a row!

Aprevent VOIS received German NUB approval for the second year in a row!

The VOIS stands out in the eyes of reviewers with special features including standardized procedure with high result-reproducibility and implant adjustability (intra- and post-operative), making revision surgeries redundant, providing patients with long-term benefits and values rise above. ...

ByAPrevent Biotech GmbH


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.


Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL Sinus Implant Reduces Healthcare Resource Utilization

Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL Sinus Implant Reduces Healthcare Resource Utilization

Study results demonstrate that patients receiving PROPEL® sinus implants following sinus surgery had lower healthcare resource utilization (HCRU) over a postoperative period of 18 months compared with patients who did not receive an implant. ...

ByIntersect ENT, 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.


Lyra Therapeutics Announces Publication of Positive LANTERN Results in the International Forum of Allergy & Rhinology

Lyra Therapeutics Announces Publication of Positive LANTERN Results in the International Forum of Allergy & Rhinology

(Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, today announced that the positive results of the Company’s Phase 2 LANTERN study of LYR-210 were published online in the peer-review ...

ByLyra Therapeutics, Inc.


Lyra Therapeutics Announces Four Abstracts Selected for Presentations at Upcoming ERS and ARS Meetings, Including New LANTERN 6-Month Follow-Up and Pharmacokinetic Data

Lyra Therapeutics Announces Four Abstracts Selected for Presentations at Upcoming ERS and ARS Meetings, Including New LANTERN 6-Month Follow-Up and Pharmacokinetic Data

New LYR-210 data from the LANTERN 6-month follow-up study and recently completed pharmacokinetic study, will be the subject of oral presentations at ARS, with the pharmacokinetic study selected as a top clinical abstract at the meeting. 28th Congress of European Rhinologic Society Presentations: Title: Long-acting implantable corticosteroid matrix for chronic ...

ByLyra Therapeutics, Inc.


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

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