Caisson Interventional Completes First in Human Implants of Its Transvascular Mitral Valve Replacement
16.9.2016 14:18 | NASDAQ OMX
MAPLE GROVE, Minn., 2016-09-16 14:18 CEST (GLOBE NEWSWIRE) --
Caisson Interventional, LLC (“Caisson” or the “Company”) announces the first successful human implants of its fully percutaneous, transvascular mitral valve implant designed as a functional replacement in a diseased, damaged, or malfunctioning mitral valve.
Mathew R. Williams, M.D. and his team from the Heart Valve Center at NYU Langone successfully implanted three patients with the Caisson Transcatheter Mitral Valve System. These are the first patients enrolled in the PRELUDE Study (Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study). The study is designed to provide initial data on the safety and performance of the Caisson TMVR System. The U.S. Food and Drug Administration (FDA) approved the Investigational Device Exemption (IDE) for the PRELUDE study under the Early Feasibility Study program for up to 20 patients in 5 centers.
The Company also reports one patient was successfully implanted in July under the direction of Eric Cohen, M.D. and Gideon Cohen, M.D. at the Schulich Heart Centre at Sunnybrook Health Sciences Centre (Toronto) under the Health Canada Special Access Programme.
The physicians involved stated the patients responded very well to the implant with excellent valve function. They also commented the delivery system performed as designed and facilitated proper placement of the implant with precise control at each step of the procedure.
Dr. Williams, NYU Langone’s chief of Adult Cardiac Surgery, and director of Interventional Cardiology and Structural Heart commented, “NYU Langone is a recognized world leader in cardiac care and we are dedicated to bringing the most advanced minimally-invasive technologies to our patients. We are proud to be the first medical center in the world to successfully implant three high risk patients with Caisson’s cutting-edge new technology to treat their severe symptomatic mitral regurgitation. Thanks to NYU Langone’s focus on innovation in the field, and the FDA’s dedication to the Early Feasibility Study (EFS) Program, we have the opportunity to be involved with this first-in-class technology at the earliest stage of clinical evaluation.”
The Caisson implant consists of two components; an Anchor constructed of a Nitinol frame and a pericardial tissue Valve attached to a Nitinol frame. The implant is fully repositionable and retrievable and only released after the function of the implant is fully assessed. The entire procedure is completed through a single percutaneous femoral venous access utilizing a trans-septal approach to the native mitral valve.
Caisson Interventional CEO C.J. Schweich Jr., M.D. said, “We are thankful to the NYU Langone and Sunnybrook teams for their dedication to outstanding patient care and participation in this groundbreaking clinical experience. These initial implants mark a significant milestone for Caisson’s technology in understanding its potential to benefit a significant number of patients with severe mitral regurgitation and limited therapeutic options.”
About the company: Caisson Interventional, LLC. is a privately held clinical-stage medical device company located in the Minneapolis area focused on the design, development, and clinical evaluation of a novel percutaneous mitral valve replacement system. The Caisson Mitral Valve Replacement System is approved for investigational use in the United States and therefore limited by Federal (or United States) law to investigational use only.
Caisson Interventional, LLC
C.J. Schweich, Jr., M.D.
Chief Executive Officer
Om NASDAQ OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40 | Pressemelding
Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid
Abeona Therapeutics Announces Pivotal Expansion of ABO-102 Gene Therapy Clinical Trials in Sanfilippo Syndrome Type A16.8.2017 15:38 | Pressemelding
NEW YORK and CLEVELAND, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, today announced the pivotal expansion of its gene therapy clinical trials for patients with MPS IIIA in the USA, Europe and Australia. "We have completed the necessary regulatory and ethical committee approvals and site initiations in Europe and Australia in order to accelerate enrollment," stated Juan Ruiz, M.D., Ph.D., Abeona's Chief Medical Officer. "We remain very encouraged by the improvements observed in clinically relevant biomarkers post-dosing of ABO-102, including durable reductions in heparan sulfate measured in the CNS, reduction of organ disease pathology, and signals of CNS improvement or stabilization at one-year follow-up in Cohort 1 subjects, and look forward to providing a more fulsome clinical update at important clinical
CallidusCloud Wins Eight Gold Stevies® in the 2017 International Business Awards16.8.2017 14:00 | Pressemelding
CallidusCloud Lead to Money suite recognized as Best B2B New Product of the Year. LeadRocket voted Best New Product or Service of the Year in the Software - Lead Generation Solution category. DUBLIN, Calif., Aug. 16, 2017 (GLOBE NEWSWIRE) -- Callidus Software Inc. (NASDAQ:CALD), a global leader in cloud-based sales, marketing, learning, and customer experience solutions, announced today that it was named the winner of eight Gold Stevie® awards in the 2017 International Business Awards. "The eight Stevie® awards earned highlight CallidusCloud's momentum, commitment to excellence, passion for innovation and customer orientation," said Leslie Stretch, president and CEO of CallidusCloud. "They also recognize the benefits that the Lead to Money suite, honored as the Best New Product in Business-to-Business, accrues to its customers in terms of enabling faster, bigger, and more profitable sales." CallidusCloud's Go
Ascom Myco and Koutio Médipôle optimize care communications and responsiveness16.8.2017 08:00 | Pressemelding
Ascom Holding AG / Ascom Myco and Koutio Médipôle optimize care communications and responsiveness . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Enabled by the Ascom Myco smart device, the new Koutio Médipôle is realizing improved care delivery through seamless information flow from the point of care to anywhere. BAAR, Switzerland, Aug. 16, 2017 (GLOBE NEWSWIRE) -- The new Koutio Médipôle hospital in the New Caledonian capital Nouméa, located in the southwest Pacific Ocean, has optimized patient care communications and responsiveness for the new 645-bed facility by deploying Ascom Myco Wi-Fi devices to support clinician teams and Ascom Myco Wi-Fi/GSM handsets, used across paramedic teams. The Ascom solution is seamlessly aligned with clinical workflow and applications (nurs
VistaJet Harnesses the Power of the American Eclipse to Offer Customers a Rare Viewing Opportunity15.8.2017 18:40 | Pressemelding
VistaJet invites customers to fly in parallel with an astronomical anomaly NEW YORK, Aug. 15, 2017 (GLOBE NEWSWIRE) -- VistaJet, the first and only global aviation company, will be offering customers the opportunity to experience and chase the American Solar Eclipse, appearing for the first time in 99 years on August 21, 2017. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c0c41d7d-7ad9-4a46-9d2d-dcc1148b4772 The coast-to-coast National Eclipse and astronomical phenomenon will be visible in the United States from approximately 10:15AM PST, with the sun disappearing behind the moon from the Oregon coast, passing through 14 states to South Carolina. Without being in this 70-mile strip, Americans will not be able to see the sun eclipsed in totality. With unparalleled experience flying into and out of the hardest to reach destinations, VistaJet is offer
NGX Bio Raises $3 Million to Fund Growth of Its DNA Sequencing Marketplace15.8.2017 17:00 | Pressemelding
SAN FRANCISCO, Aug. 15, 2017 (GLOBE NEWSWIRE) -- NGX Bio, Inc., (www.NGXbio.com) the premier marketplace for online DNA sequencing services, announced it has closed a $3 million funding round. The round was led by 180 Degree Capital Corp. (NASDAQ:TURN) and included Third Kind Venture Capital, Lateral Capital, the Band of Angels and the Berkeley Angel Network, as well as other investors. NGX Bio was founded in 2014 to provide streamlined, on-line access to next-generation sequencing services for clients seeking high quality, rapid and cost-effective sequencing of both human and non-human samples globally. Demand for sequencing services is growing exponentially. NGX Bio's platform matches the sequencing needs of customers with providers who have available sequencing capacity. Customers are able to purchase a wide range of sequencing services for their samples using NGX Bio's online ordering tools. NGX Bio offers these services through numerous and deep relationships with its
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom