Caisson Interventional Completes First in Human Implants of Its Transvascular Mitral Valve Replacement
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 GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Canada's CoinField cryptocurrency exchange going international with commission-free trading app moonGO through a new partnership23.7.2018 11:30 | Pressemelding
moonGO(TM) app is the fastest and most reliable way to buy/sell and store cryptocurrencies. The app allows users to convert cryptos directly to EUR/USD to be loaded into their moonGo(TM) card and be used anywhere worldwide whether they're shopping online or spending it at a physical retailer who accepts credit cards. VANCOUVER, British Columbia, July 23, 2018 (GLOBE NEWSWIRE) -- CoinField, the most advanced cryptocurrency exchange in Canada is now extending its services worldwide thanks to a new partnership with Malta's Manticore Ventures to create moonGO(TM), a powerful app designed for traders who thrive on agility, flexibility and security. With moonGO(TM), users can set up their trading accounts in about 60 seconds, withdraw fiat currency as Euro or US dollars in the form of moonGO(TM) cards, and use the moonGO(TM) cards to make purchases online or at any retailer that accepts credit cards. The moonGO(TM) app will take CoinField's sterling reputation outside of Canada and make its
UK drafts new M. genitalium guidelines: Resistance Guided Therapy to tackle antibiotic resistance23.7.2018 09:00 | Pressemelding
BASHH aiming to raise awareness of Mgen and curb rising antibiotic resistance LONDON, July 23, 2018 (GLOBE NEWSWIRE) -- The British Association of Sexual Health and HIV (BASHH) draft guidelines for the sexually transmitted infection Mycoplasma genitalium (Mgen) were posted for consultation on July 8th, 20181[link]. The guideline recommends Resistance Guided Therapy as best practice when treating an Mgen infection, with a strong recommendation for diagnostic tests to direct appropriate antibiotic treatment. Mgen is highly resistant to antibiotics, up to 50% of infections are already resistant to the first-line treatment, azithromycin.2,3 This rate may rise if infections are treated without knowledge of resistance status. The success of Resistance Guided Therapy as treatment for Mgen was published in Clinical Infectious Diseases, June 20182 [link].Cure rates increased from under 68% to over 92% by switching the first-line drug and using the SpeeDx Resistance Plus® MG* test to triage pati
Gratomic Announces Non-Brokered Private Placement21.7.2018 19:41 | Pressemelding
TORONTO, July 21, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. ("GRAT" or the "Company") (TSX-V:GRAT) (FRANKFURT:CB81) (WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 20,000,000 working capital units (the "WC Unit") for up to $2,000,000 (the "Offering"). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant ("WC Warrant"). Each WC Warrant entitles the holder to purchase one (1) common share (a "WC Warrant Share") at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the "Final Trading Day") is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of
eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30 | Pressemelding
SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with
Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39 | Pressemelding
DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s
Second Quarter 2018 Results Conference Call19.7.2018 21:34 | Pressemelding
AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 www.magna.com Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations email@example.com, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations firstname.lastname@example.org, 905-726-7108 This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originali
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom