CE marked implant News
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KiOmed Pharma obtains CE mark and signs a License and Supply Agreement
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 first implantable product intended to treat osteoarthritis symptoms and the signing of a ...
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Berlin Heart Received CE Mark and Announces First Implantation of the Latest Cannula Generation to Treat Heart Patients Waiting for a Donor Heart
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 EXCOR® Graft Cannula* connects the outflow side of the blood pump to the ascending aorta for left ventricular support or to the pulmonary artery for right ...
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Orchestra BioMed Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy
Clinically meaningful and statistically significant reduction in systolic blood pressure is consistent with the decrease previously observed in the study treatment group during the same time period. Ambulatory Systolic Blood Pressure (aSBP) decreased by an average of 10.3 mmHg (p Office Systolic Blood Pressure (oSBP) decreased by an average of 13.1 and 20.9 mmHg at 6 and 12 months, ...
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Orchestra BioMed to Present at the Innovation in Cardiovascular Interventions Meeting and the CSI Focus D-HF Congress
Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced upcoming presentations at the Innovation in Cardiovascular Interventions (ICI) Meeting in Tel-Aviv, Israel, taking place December 8-10, 2019 and the CSI Focus D-HF Congress in ...
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Orchestra BioMed Announces Clinical Data Showing Significant and Sustained Reduction in Systolic Blood Pressure Out to Two Years with BackBeat Cardiac Neuromodulation Therapy
Clinically meaningful and statistically significant reduction of 16.6 mmHg in systolic blood pressure out to two years 88% of the treated patients had isolated systolic hypertension (ISH) 70.6% of all treated patients and 80% of treated ISH patients had their blood pressure under control at 24 months Orchestra BioMed™, Inc., (“Orchestra BioMed” or the ...
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Orchestra BioMed Announces Late-Breaking Clinical Results Showing BackBeat Cardiac Neuromodulation Therapy Drives Significant Reduction in Systolic Blood Pressure
Double-blind, randomized trial data demonstrates clinically meaningful and statistically significant difference of 8.1 mmHg in reduction of 24-hour ambulatory systolic blood pressure at 6 months vs. control High responder rate despite 88.5% of treated patients having isolated systolic hypertension (ISH) Primary safety endpoint achieved with no difference in major cardiac adverse events ...
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Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy
Double-blind, randomized trial data show a clinically meaningful and statistically significant net reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure at 6 months in treated vs. control patients Very high (85%) response rate to therapy despite 81% of treated patients having isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of hypertension ...
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Avery Biomedical Letter to Medscape Regarding Diaphragm Pacing
Please find below a letter that our attorney sent to the editors of Medscape (parent company WebMD) who have published false information about our product. Medscape Letter Regarding Avery System Avery Biomedical Devices has an outstanding track record spanning over 45 years including an outstanding safety record, long term viability with some patients pacing for more than 35 years, and ...
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BioPoly Granted US Patent for Its Implant Technology
FORT WAYNE, IN – BioPoly LLC has announced that another U.S. patent has been granted for its partial resurfacing implants which protects the innovative implant designs. The Company’s intellectual property portfolio also consists of patents that address its unique BioPoly® material. This most recent patent further adds to the Company’s IP portfolio, providing assurance that ...
By BioPoly, LLC
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BioPoly Granted an International Patent for Its Implant Technology
FORT WAYNE, IN – BioPoly LLC has announced that the Company has further expanded its intellectual property portfolio. 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 ...
By BioPoly, LLC
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Empirical Spine Closes $10 Million Series B Financing
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced the closing of a Series B financing of $10 million. SHD (Scientific Health Development) led the round, with additional investment from GP&G (Green Park & Golf) and other syndicate members. The funds will be used to advance the product on its path to market, including completing the ongoing pivotal trial ...
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Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or ...
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Amsel Medical Announces $1.5 million AFWERX TACFI Grant Award
Amsel Medical Corporation today announced receipt of award and signing of a contract for a non-dilutive AFWERX Tactical Funding Increase (TACFI) of $1.5 million augmenting its original $1M Phase II SBIR Grant. This effort is sponsored by the Air Force Research Laboratory and will enable Amsel Medical to bridge its Phase II efforts towards Phase III commercial scaling. It facilitates the delivery ...
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Cardiac Dimensions Announces $17.5 Million Series C Financing to Accelerate Sales Expansion of the Carillon Mitral Contour System
Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the company has closed a $17.5 million Series C financing. All existing shareholders participated in the round including Aperture Venture Partners, Arboretum Ventures, Hostplus, Life Sciences Partners, Lumira ...
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Lattice Medical announces the closing of a €8 million Series A financing round
LATTICE MEDICAL, announces the closing of a second round of financing of 8 million euros. This round was led by the historical funds Finovam Gestion, Nord France Amorçage and WiSEED alongside the Captech Santé fund. The European Commission, via its EIC Fund, and Santelys are co-investing. The financing round is completed by non-dilutive financing, in the form of a grant and debt ...
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Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in the investigational arm of its U.S. IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal ...
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Cardiac Dimensions Reaches 1,000 Implants of Carillon System, a Minimally Invasive Treatment for Functional Mitral Regurgitation
Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the Carillon Mitral Contour System® has been implanted in 1,000 patients in the United States, Europe, Australia, Turkey and the Middle East. The Carillon System is a right-heart transcatheter mitral valve ...
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Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) ...
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New Data Shows The Carillon Mitral Contour System Is Associated With Improvement In Regurgitant Volume In Patients With Increased Mitral Valve Tenting
Cardiac Dimensions, a leader in the development of minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, presented data at the TVT2019 Structural Heart Summit showing increased mitral valve tenting is associated with an improvement in regurgitant volume with the Carillon Mitral Contour System®. The Carillon System is a right-heart ...
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Orchestra BioMed Secures $20 Million Financing Facility from Silicon Valley Bank
Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced that it has entered into a $20 million credit facility agreement with Silicon Valley Bank (SVB), the bank of the world’s most innovative companies and their investors. This ...
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