TOKYO, Japan and BUELACH, Switzerland – BIOTRONIK announced today market approval for its Orsiro 1 coronary drug-eluting stent (Orsiro DES) by the Japanese Ministry of Health. BIOTRONIK won FDA approval for its Orsiro drug-eluting coronary stent, an ultrathin device that's already been approved in Europe for eight years and has Popular Medicine Orsiro de BIOTRONIK, le premier stent à élution médicamenteuse hybride de l'industrie, réalise les meilleures performances de sa catégorie. BIOTRONIK has announced CE Mark certification for the Orsiro® Mission drug-eluting stent (DES) system. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimuseluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. During the attempt to insert the stent system it was noticed that the stent was already deformed. Interestingly, the risk of stent thrombosis was very low in both groups, but the advantage went to Resolute Onyx. SAN FRANCISCO, CA—A head-to-head comparison of two coronary stents with biodegradable polymers in an all-comers population showed that the Orsiro ultrathin strut drug-eluting stent (Biotronik) was noninferior to the BioMatrix stent (Biosensors) with conventional strut thickness. This is innovation that matters for hospital administrators, physicians and their patients, who deserve the best outcomes.” Biotronik said today it enrolled the 1st patient in its new Chinese Bioflow-VI study of its Orsiro drug-eluting stent for treating patients with coronary artery disease.. Correction: This story has been corrected to reflect that Orsiro is the only ultrathin-strut stent available in the United States. Orsiro coronary drug-eluting stent receives market approval in Japan. February 12, 2020—Biotronik has announced CE Mark certification for its Orsiro Mission drug-eluting stent (DES) system. The prospective, multi-center trial is slated to enroll 440 patients at 15 sites in China to support Chinese market approval of the Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company's Biolute bioabsorbable polymer coating. 1. Kandzari D et al. BIOTRONIK’s covered stent is designed to save more lives and to help avoid emergency bypass surgeries, which come with increased risk for patients and can be costly for hospitals. BIOTRONIK Xience Prime/ Xpedition Abbott SORT-OUT VII5,6 (n=2,314 patients) Orsiro BIOTRONIK Nobori Terumo 0 TLF at 12 months (%) 5 10 4.0 3.8 6.5 4.2 4.6 4.5 6.6 >32,500 patients enrolled >50,500 patients planned in total >44 studies ongoing >55 studies planned in total *status as of Feb 2017 ST - Stent Thrombosis The Orsiro device is a hybrid drug-eluting stent that represents a new strategy in the treatment of coronary artery stenosis. Lancet. Photo Credit: Biotronik Biotronik said today that China's National Medical Products Administration approved its Orsiro drug-eluting stent. LAKE OSWEGO, Ore., Feb. 22, 2019 /PRNewswire/ -- BIOTRONIK today announced FDA approval of the Orsiro drug-eluting stent (DES) system. 2017 Oct 21; 390(10105):1843-1852; 2. TCT 2017: BIOTRONIK’s Orsiro drug-eluting stent shows low five-year event rates in BIOFLOW-II RCT and BIOFLOW-III registry DENVER, United States and BUELACH, Switzerland – BIOTRONIK ’s Orsiro 1 drug-eluting stent (DES) demonstrated high long-term safety and clinical performance according to 60-month follow-up data presented during TCT 2017. Contraindications: Orsiro is contraindicated for use in patients with a known hypersensitivity or allergy to the stent and/or stent coating materials such as amorphous silicon carbide, PLLA polymer, L-605 cobalt chromium alloy (including the major elements cobalt, chromium, tungsten and nickel), sirolimus … Biotronik said it plans to have Orsiro on the Chinese market "in the coming months." This Brand Name Synsiro is applied by Biotronik Ag who has a business location at Ackerstr.6, 8180 Bulach, Switzerland as per this application.. Among the 1,243 patients treated with the thin-wire stent, there was just one case of definite or probable stent thrombosis compared with nine cases in … The next generation of the company’s ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents. While the EluNIR stent is a made up of a combination of supportive struts ranging in widths, struts are relatively thick at 90 µm, which is similar to other commercially available stents. SAN DIEGO – Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest. eSutures sells discounted, brand name sutures, suture material and endomechanicals. The Orsiro stent system provides ultrathin stent struts without compromising radial strength and a low crossing profile for easier lesion cross in complex PCI. Biotronik yesterday presented two-year data from a trial comparing Boston Scientific's (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik's Orsiro sirolimus-eluting stent and Medtronic's (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent. Orsiro is the first and only ultrathin DES to outperform the clinical standard, Xience. In February 2019, Biotronik’s Orsiro stent received approval from the US Food and Drug Administration after study results revealed that it set new standards for safety and efficacy clinical endpoints. BIOTRONIK introduces next generation drug-eluting stent system in the CE region READ ARTICLE. BIOTRONIK has announced CE Mark certification for the Orsiro ® Mission drug-eluting stent (DES) system. FDA Approves BIOTRONIK's Ultrathin Orsiro Stent for the Treatment of Coronary Artery Disease. "Orsiro will be a valuable addition to our… We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. This Application has been filed by their agent ANAND AND ANAND. 1,2 Orsiro received CE marking in 2011 and has been used to treat more than one million patients worldwide to date. The latest readout comes from a study of 1,300 acute myocardial infarction patients. ESC Congress 2017: BIOTRONIK’s Orsiro drug-eluting stent outperforms Xience in BIOFLOW-V trial BARCELONA, Spain – BIOTRONIK today announced data from the BIOFLOW-V randomized trial comparing Orsiro * and Xience ** drug-eluting stents (DES) with 12-month target lesion failure (TLF) as the primary endpoint proving non-inferiority. Orsiro Mission, which is the next generation of the company’s ultrathin-strut Orsiro DES, is now available in countries that recognize CE Mark. This was supported by the positive 12-month outcomes of the BIOFLOW-IV clinical study which were presented at the 81st Japan Circulation … BIOTRONIK today announced FDA approval of the Orsiro drug-eluting stent (DES) system. Ultrathin bior The next generation of the company’s ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents. “Orsiro’s consistently better long-term outcomes completely alter the dynamic of what had become a highly commoditised DES market,” said Ryan Walters , president at Biotronik. The Orsiro cobalt chromium metal stent elutes sirolimus via BIOluteTM, BIOTRONIK’s bioabsorbable polymer coating. Since then, Biotronik has continued to gather evidence its stent outperforms its older rivals. 1 Orsiro Mission is now available in CE Mark countries. Kandzari D et al. Orsiro Mission is now available in CE Mark countries. Updated June 13, 2013, 2:16 AM. Beneath the bioabsorbable layer is BIOTRONIK’s proBIOTM coating, a silicon carbide layer covering the bare metal surface and designed to reduce nickel ion release. 3 2.25 - 3.0 mm stent In-stent late loss [mm] at 9 months 2 Orsiro Xience Prime 0.10 0.11 p-value for non-inferiority < 0.001 Performs as best in class n Orsiro uses the proven PRO-Kinetic Energy platform that offers exceptional bending flexibility without compromising scaffolding or fatigue resistance. Biotronik will face competition from more modern devices than Resolute Integrity as it tries to carve out a space for Orsiro. Biotronik said it launched a U.S. investigational device exemption trial of its Orsiro hybrid drug-eluting stent, the Bioflow-V study.. TCT 2018 – ultrathin Orsiro DES: wealth of clinical evidence for novel technology READ ARTICLE. This Trademark was applied on date 21 November 2013. BIOTRONIK is releasing the Orsiro, the world’s first hybrid drug-eluting stent, in the French market. Orsiro Achieves Statistically Lower Clinical Event Rates and … Trademark Details. Read full article. The synsiro drug eluting stent system was chosen for the treatment. Dive Insight: Biotronik received premarket approval for Orsiro in February on the strength of clinical data linking it to a lower two-year TLF rate than Xience in patients with ischemic heart disease. The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

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