GlobeNewswire

Intuitive Surgical Receives CE Mark for Latest da Vinci® Robotic-Assisted Surgical System

Dela

New da Vinci X(TM) Surgical System provides lower-cost, robotic-assisted surgical option for hospitals, surgeons

AUBONNE, Switzerland, April 26, 2017 (GLOBE NEWSWIRE) -- Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe. The da Vinci X System will provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0c20bf18-fcc5-4d29-8bab-4ada1ab29eae

The launch of the da Vinci X System underscores Intuitive's commitment to meeting customers' needs with a strong value-oriented portfolio of cost-appropriate technologies and an array of financing options.

"Over the past 21 years, Intuitive Surgical pioneered robotic-assisted surgery and we continue to lead the way in developing and bringing to market innovative technologies, outcomes-focused products and value-oriented solutions," said Dr. Gary Guthart, CEO of Intuitive Surgical. "Our surgeon, hospital and healthcare customers around the world told us that robotic-assisted surgery matters for their programs and their patients while underscoring the importance of providing choice from a clinical, technological and cost standpoint. The da Vinci X product offering provides a lower-cost solution to meet the needs of customers who want a choice in price points, while offering access to many of our recent innovations."

The da Vinci X System offers surgeons and hospitals access to Intuitive's portfolio of advanced, innovative robotic-assisted surgical technologies - and its full ecosystem of programs, support, services, and solutions -at a lower price.  The System uses the same vision cart and surgeon consoles that are found on our flagship product, the da Vinci Xi ® System, enabling our customers the option of adding advanced capabilities, and providing a pathway for upgrading should they choose to do so as their practice and needs grow.

The da Vinci X System enables optimized, focused-quadrant surgery including for procedures like prostatectomy, partial nephrectomy, hernia repair, benign hysterectomy and sacrocolpopexy, among others. The System features flexible port placement and state-of-the-art 3D digital optics, while incorporating the same advanced instruments and accessories as Intuitive's flagship system. The new system drives operational efficiencies through set-up technology that uses voice and laser guidance, drape design that simplifies surgery prep, and a lightweight, fully integrated endoscope.

"The da Vinci X System is a value-oriented, highly capable offering that meets - and responds to - our customers' economic and clinical needs," said Damien Desmedt, General Manager of Intuitive Surgical in the United Kingdom, Ireland, and Nordic countries. "In the countries we serve around the globe, we know that customers have different needs and wants, and we strive to provide an array of choices to meet their needs today and in the future. The da Vinci System helps us to continue to do this."

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci Surgical System.

About the da Vinci Surgical System

There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the procedure is performed entirely by a surgeon who controls the system. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The System can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.  The System is indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures).  It is intended to be used by trained physicians in an operating room environment.

The da Vinci X Surgical System is a class 2b CE 0543 marked medical device under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc.  Refer to the Instructions For Use before use.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci X System in the US. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2016, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. Statements using words such as "estimates," "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," "targeted" and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

© 2017 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

PN1035581rA EU 4/2017

Contact
JPA Health Communications
kperry@jpa.com
+44203 884 0650



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 originality of the information contained therein.
Source: Intuitive Surgical, Inc. via Globenewswire

Om

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Arcoma AB: Arcoma presenterar på Redeye Life Science Day den 21:a november16.11.2018 12:53Pressmeddelande

16 November Den 21 november presenterar Jesper Söderqvist, VD på Arcoma, den senaste utvecklingen i Arcoma på Haymarket by Scandic i Stockholm. Presentationen "Arcoma, ett tillväxtbolag i en växande marknad" hålls klockan 13:00 och kan följas i livesändning på redeye.se/live/lsday-2018. Presentationen kommer även i efterhand att finnas tillgänglig på www.redeye.se/live/ls-day-2018 samt på Bolagets sida i Redeye Universe (redeye.se/company/Arcoma) Om Arcoma Arcoma, med lång erfarenhet av branschen, är en ledande leverantör av integrerade digitala röntgensystem med hög kvalitet och avancerad teknik. Arcomas produkter erbjuder den senaste digitala bildtekniken kombinerat med tekniskt avancerade rörliga positioneringssystem, vilket tillsammans med ergonomisk skandinavisk design, erbjuder kunden kompletta, konfigurerbara och funktionella digitala röntgensystem. Bolagets produkter säljs via återförsäljare samt via OEM-kunder och det finns idag över 3 500 av Arcomas röntgensystem installerade

Iconovo: kundprojekt blir framflyttat tre till sex månader8.11.2018 15:45Pressmeddelande

Fortsatt arbete med ett av Iconovos pågående kundprojekt kommer att flyttas fram tre till sex månader. Projektet avser utveckling av produkt anpassad för kund som ska svara för produktion och marknadslansering. Det aktuella arbetet var planerat att ske under fjärde kvartalet men beräknas ske under nästa år, och detta påverkar Iconovos omsättning under 2018 negativt med cirka 2 miljoner kronor. Orsaken är att kunden har beslutat att genomföra en mindre klinisk studie för att verifiera produkten innan nästa steg tas vilken omfattar investeringar i betydande mångmiljonbelopp i produktionskapacitet, baserat på Iconovos utveckling. Studien görs för kundens egna räkning och är inte villkorad av tillsynsmyndigheter. "Detta påverkar vårt resultat på kort sikt, men det faktum att kunden har beslutat att göra en betydande investering i faktisk produktion betyder att vi med stor säkerhet kan se fram emot licensintäkter under en lång tidsrymd framöver i samband med att produkten lanseras på markna

Stillfront Group AB: Inbjudan till Stillfront Groups kvartalsrapport för tredje kvartalet 20187.11.2018 14:34Pressmeddelande

PRESSMEDDELANDE 7 november 2018 Inbjudan till Stillfront Groups kvartalsrapport för tredje kvartalet 2018 Stillfront Groups kvartalsrapport för det tredje kvartalet 2018 kommer att publiceras klockan 07.00 den 22 november 2018. En webbsänd telefonkonferens kommer att hållas klockan 10.00 samma dag där Jörgen Larsson, VD och Sten Wranne, CFO, kommenterar resultatet. Presentationen och rapporten kommer efter presentationen att finnas tillgänglig på www.stillfront.com Webbsändningen nås på adressen: https://tv.streamfabriken.com/stillfront-q3-2018 För att delta via telefon, vänligen ring: SE: +46 8 566 426 63 UK: +44 20 300 898 01 US: +1 8 557 532 235 FÖR YTTERLIGARE INFORMATION, VÄNLIGEN KONTAKTA: Sofia Wretman, IR Phone: +46 708 11 64 30 sofia@stillfront.com OM STILLFRONT Stillfront är en oberoende utvecklare, förläggare och distributör av digitala spel - med visionen att bli en ledande indie-spelutvecklare och förläggare. Stillfront är verksamt genom tio näst intill självständiga dotte

Stillfront Group AB: Invitation to Stillfront Group Q3 presentation7.11.2018 14:34Pressmeddelande

Invitation to Stillfront Group Q3 presentation Stillfront Group interim report for the third quarter 2018 will be published at 07.00 CET on 22 November 2018. A presentation of the report will be held the same day at 10.00 CET via telephone conference or audiocast where Jörgen Larsson, CEO and CFO Sten Wranne are to comment on the report. The presentation can be viewed live at https://tv.streamfabriken.com/stillfront-q3-2018 To participate via phone please call: SE: +46 8 566 426 63 UK: +44 20 300 898 01 US: +1 8 557 532 235 FOR FURTHER INFORMATION, PLEASE CONTACT: Sofia Wretman, IR Phone: +46 708 11 64 30 sofia@stillfront.com ABOUT STILLFRONT Stillfront is a group of independent creators, publishers and distributors of digital games - with a vision to become the leading group of indie game creators and publishers. Stillfront operates through ten near-autonomous subsidiaries: Bytro Labs in Germany, Coldwood Interactive in Sweden, Power Challenge in the UK and Sweden, Dorado Online Games

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease7.11.2018 08:30Pressmeddelande

STOCKHOLM, November 7, 2018. Karolinska Development's portfolio company Modus Therapeutics announces today that the U.S Food & Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to initiate a Phase I clinical trial with subcutaneous sevuparin for the treatment of sickle cell disease (SCD) FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD. At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, t

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease7.11.2018 08:30Pressmeddelande

STOCKHOLM, November 7, 2018. Karolinska Development's portfolio company Modus Therapeutics announces today that the U.S Food & Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to initiate a Phase I clinical trial with subcutaneous sevuparin for the treatment of sickle cell disease (SCD) FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD. At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, t

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum