Neurosurgical procedures

FDA Approves First-Of-Its-Kind Percept™ PC Neurostimulator with BrainSense™ Technology

Retrieved on: 
Thursday, June 25, 2020

DUBLIN, June 25, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announces it received Food and Drug Administration (FDA) approval for the Percept PC Deep Brain Stimulation (DBS) system.

Key Points: 
  • DUBLIN, June 25, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announces it received Food and Drug Administration (FDA) approval for the Percept PC Deep Brain Stimulation (DBS) system.
  • BrainSense technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinsons disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder (OCD).
  • Mayo Clinic in Rochester, Minn., will be the first in the United States to implant the newly approved device.
  • For further information on the Percept PC Neurostimulator with Brainsense Technology, please visit: Medtronic.com/Percept .

SeaSpine Announces Limited Commercial Launches of NorthStar™ OCT and Cervical Facet Fusion™ Systems

Retrieved on: 
Monday, June 22, 2020

CARLSBAD, Calif., June 22, 2020 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launches and completion of initial surgeries of both its NorthStar OCT and Cervical Facet Fusion systems, which significantly expand its procedural offerings for posterior cervical fusion.

Key Points: 
  • CARLSBAD, Calif., June 22, 2020 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launches and completion of initial surgeries of both its NorthStar OCT and Cervical Facet Fusion systems, which significantly expand its procedural offerings for posterior cervical fusion.
  • We are extremely excited about the alpha release of NorthStar OCT, said Dennis Cirino, Senior Vice President, Global Spinal Systems.
  • The Cervical Facet Fusion system was designed to be a simple and complementary graft delivery solution to posterior cervical fusions.
  • The launches of both the NorthStar OCT and Cervical Facet Fusion systems reflect SeaSpines desire to provide comprehensive procedural solutions to the global spine market and its surgeon customers.

Spinal Elements® Introduces its MIS Ultra™ Platform of Products and Procedures Designed to Minimize the Unintended Consequences of Spine Surgery

Retrieved on: 
Wednesday, June 17, 2020

Spinal Elements, a Carlsbad, CA-based medical device company focused on spine surgery procedures, today introduced its MIS Ultra platform of products and procedures.

Key Points: 
  • Spinal Elements, a Carlsbad, CA-based medical device company focused on spine surgery procedures, today introduced its MIS Ultra platform of products and procedures.
  • View the full release here: https://www.businesswire.com/news/home/20200617005159/en/
    Spinal Elements Introduces its MIS Ultra Platform of Products and Procedures Designed to Minimize the Unintended Consequences of Spine Surgery (Graphic: Business Wire)
    Traditionally, MIS procedures have been focused on the size of the incision required for access to the spine.
  • The MIS Ultra product suite goes beyond small incisions to consider the implications of spine surgery after the procedure has taken place.
  • Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery.

Providence Medical Technology Announces First Patient Enrollment in the "FUSE" IDE Clinical Study

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Monday, June 15, 2020

The study is designed to demonstrate that Circumferential Cervical Fusion (CCF) achieves superior clinical outcomes versus ACDF for the treatment of 3-level cervical degenerative disc disease.

Key Points: 
  • The study is designed to demonstrate that Circumferential Cervical Fusion (CCF) achieves superior clinical outcomes versus ACDF for the treatment of 3-level cervical degenerative disc disease.
  • Providence CEO & Co-founder, Jeff Smith, explained the importance of the FUSE Study: "Our purpose at Providence is to improve clinical outcomes for high-risk patients and prevent surgical failures of the cervical spine.
  • The FUSE Study is an important next step towards that goal, and we are grateful for the support and dedication of our clinical investigators."
  • Providence Medical Technology, Inc. is a privately held medical device company focused on innovative and tissue-sparing surgical solutions for cervical spine surgery.

OrthoPediatrics Corp. Commences Initial U.S. Launch of ApiFix’s FDA-Approved Spinal Deformity Correction System

Retrieved on: 
Wednesday, June 10, 2020

WARSAW, Ind., June 10, 2020 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (OrthoPediatrics or the Company) (Nasdaq:KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, is pleased to announce the initial U.S. launch of the ApiFix Minimally Invasive Deformity Correction (ApiFix) system.

Key Points: 
  • WARSAW, Ind., June 10, 2020 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (OrthoPediatrics or the Company) (Nasdaq:KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, is pleased to announce the initial U.S. launch of the ApiFix Minimally Invasive Deformity Correction (ApiFix) system.
  • It enables surgeons to perform a unique treatment and provide permanent curve correction while retaining spine flexibility, all via a less invasive surgical procedure compared to spinal fusion.
  • The ApiFix system offers a patented unidirectional, self-adjusting rod mechanism and motion-preserving polyaxial joints, allowing additional post-operative correction over time.
  • ApiFix, a leader in motion-preserving scoliosis correction, was recently acquired by OrthoPediatrics in April 2020 and operates as a wholly-owned subsidiary based in Israel.

Surgical Information Sciences Announces CE Mark for its DBS Visualization Guiding System

Retrieved on: 
Tuesday, June 2, 2020

PLYMOUTH, Minn., June 2, 2020 /PRNewswire/ --Surgical Information Sciences (SIS), a medical device company focused on improved visualization of targets for deep brain stimulation (DBS) surgery, announced completion of requirements to apply CE Mark to market its visualization capabilities in Europe.

Key Points: 
  • PLYMOUTH, Minn., June 2, 2020 /PRNewswire/ --Surgical Information Sciences (SIS), a medical device company focused on improved visualization of targets for deep brain stimulation (DBS) surgery, announced completion of requirements to apply CE Mark to market its visualization capabilities in Europe.
  • Post-procedurally, the SIS System provides 3D visualization of the predicted location of the STN relative to the implanted DBS leads, including the identification of the lead contacts.
  • "We are pleased to announce completion of the requirements to apply CE Mark in Europe," said Brad Swatfager, President and Chief Executive Officer.
  • "Surgeons are seeking significant improvements in visualizing brain anatomy for targeting in DBS procedures and the SIS System provides the most accurate capabilities in existence.

Global Deep Brain Stimulation Devices Industry (2019 to 2026) - by Application and End-user - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 2, 2020

The "Global Deep Brain Stimulation Devices Market by Application and End User: Opportunity Analysis and Industry Forecast, 2019-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Deep Brain Stimulation Devices Market by Application and End User: Opportunity Analysis and Industry Forecast, 2019-2026" report has been added to ResearchAndMarkets.com's offering.
  • Deep brain stimulation devices send electrical impulse to the spine region wherein these signals block the pain signals from reaching the brain.
  • Deep brain stimulation monitoring devices are particularly used for the treatment of neurological disorders such as epilepsy, chronic pain, Parkinson's disease, depression, and other diseases.
  • The deep brain stimulation devices market is classified on the basis of application, enduser, and region.

Spine Bone Stimulator Market to Expand With 3.8% CAGR By 2024 | Key Players: IGEA S.p.A. & Orthofix Inc.: Radiant Insights, Inc.

Retrieved on: 
Tuesday, April 7, 2020

The medical process of spine fusion takes place when bone fragments heal together to create a solid bone.

Key Points: 
  • The medical process of spine fusion takes place when bone fragments heal together to create a solid bone.
  • By application, the spine bone stimulator market can be segmented as open spine surgery and minimally invasive surgery.
  • The analysts forecast the global spine bone stimulator market to exhibit a CAGR of 3.8% during the period 2019-2024.
  • Based on application, the spine bone stimulator market is segmented into:
    The report also includes a discussion of the key vendors operating in this market.

Spine Bone Stimulator Market to Expand With 3.8% CAGR By 2024 | Key Players: IGEA S.p.A. & Orthofix Inc.: Radiant Insights, Inc.

Retrieved on: 
Tuesday, April 7, 2020

The medical process of spine fusion takes place when bone fragments heal together to create a solid bone.

Key Points: 
  • The medical process of spine fusion takes place when bone fragments heal together to create a solid bone.
  • By application, the spine bone stimulator market can be segmented as open spine surgery and minimally invasive surgery.
  • The analysts forecast the global spine bone stimulator market to exhibit a CAGR of 3.8% during the period 2019-2024.
  • Based on application, the spine bone stimulator market is segmented into:
    The report also includes a discussion of the key vendors operating in this market.

V-Wave Receives CE Mark for the Ventura™ Interatrial Shunt System

Retrieved on: 
Thursday, March 5, 2020

The minimally invasive implanted Ventura Interatrial Shunt relieves excessive pressure in the left-side of the heart, thereby reducing the build-up of fluid in the lungs, which is the most common reason for worsening HF symptoms, exercise limitation, and HF hospitalizations."

Key Points: 
  • The minimally invasive implanted Ventura Interatrial Shunt relieves excessive pressure in the left-side of the heart, thereby reducing the build-up of fluid in the lungs, which is the most common reason for worsening HF symptoms, exercise limitation, and HF hospitalizations."
  • The Ventura Interatrial Shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient U.S. Food and Drug Administration (FDA) IDE pivotal trial called RELIEVE-HF , which is designed to demonstrate safety and effectiveness of shunt therapy in reducing HF morbidity and mortality and improving functional status.
  • "CE mark for the Ventura Interatrial Shunt System is a significant milestone for V-Wave, as it recognizes that this therapeutic product conforms to the standards of the European Medical Device Directive," said V-Wave CEO Neal Eigler, MD.
  • CAUTION:THE VENTURAINTERATRIAL SHUNT SYSTEM IS UNDER CLINICAL INVESTIGATION.