Ce Marked Implant Articles & Analysis
27 news found
This clinical trial will last 36 months and will lead to CE marking. This clinical investigation called TIDE, had a first successful implantation by 12th of July at the Institute of Clinical Oncology with a 63 years old patient operated with MATTISSE in the case of her breast cancer and immediate reconstruction. CE ...
The goal is to show that patients can achieve fusion-equivalent results - without the fusion. The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients. ...
Many patients are extremely interested in less invasive stabilization options that avoid the complications of fusion, so they are attracted to LimiFlex. The device is easy to implant and has demonstrated great results in Europe, which we expect to confirm in this ...
The goal is to show that patients can achieve fusion-equivalent results – without the fusion. The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients. ...
In addition to its temporary trauma solution, it is also commercializing a permanent implant (SCureClamp) that is CE mark and FDA ...
After completion of the neural decompression/laminectomy, LimiFlex is implanted through the same incision to restore stability while maintaining balanced mobility of the spine. ...
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ ...
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to ...
“The effects on ISH and Pulse Pressure are especially compelling given the prevalence of this particularly challenging form of hypertension in our initial target population of hypertensive patients indicated for a permanent pacemaker implant. We look forward to communicating next steps as we work to advance BackBeat CNT into definitive studies and towards regulatory ...
Berlin, September 2021: Berlin Heart today announces the CE mark and first implantation of an innovative outflow cannula for mechanical circulatory support with the paracorporeal pulsatile EXCOR® ventricular assist device. ...
The data demonstrated that BackBeat Cardiac Neuromodulation Therapy™ (CNT™), a programmable and adjustable bioelectronic therapy delivered via an active implantable cardiac pulse generator, significantly reduced 24-hour ambulatory systolic blood pressure (aSBP) in patients with persistent hypertension and a clinical indication for a pacemaker. ...
Avery is the only diaphragm pacing system that has FDA PMA approval and CE marketing privileges for all ages. In addition, it is ISO 13485: 2016 compliant. ...
It is also the only device of its kind with full FDA premarket approval and CE marking privileges under the European Active Implantable Medical Device Directive, and is approved for both adult and pediatric use. ...
About BackBeat CNT BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment designed to immediately, substantially, and persistently lower blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system ...
The objective of the study is to demonstrate that patients can achieve the benefits of spinal stabilization, without the complications related to fusion of vertebrae. The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European ...
ISH patients treated with BackBeat CNT demonstrated a significant reduction in oSBP of 10.6±11.1 mmHg and 14.2±20.5 mmHg (p About BackBeat CNT BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and persistently lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra ...
Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus without compromising the valve or future treatment options.2,3 The Carillon System is designed to treat the primary cause of functional mitral regurgitation in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in ...
The Company was granted another international patent for its partial resurfacing implants which protects the innovative implant designs. In addition to patents that cover the design of its implants, several U.S. and international patents have also been granted that address the Company’s unique BioPoly® material. ...
Carnegie & Co. and Hostplus, a large investor in our medical device initiative, recognized early on the importance of the Carillon System to patients and have been a significant supporter of the therapy and the company during their journey,” said Mark Carnegie of M.H. Carnegie & Co. “We’re excited now that the company has approval in Australia and look ...
KiOmed Pharma announces the granting of the CE mark for its first implantable product intended to treat osteoarthritis symptoms and the signing of a License and Supply Agreement with TRB Chemedica, a leading pharmaceutical and biotechnology company. KiOmed Pharma announces the granting of the CE mark for its ...