finanzen.net
22.09.2018 19:41
Bewerten
(0)

Late-Breaking Clinical Study Results Demonstrate Exceptional Safety and Efficacy Outcomes for Resolute Onyx(TM) DES

DRUCKEN

TCT18: BIONYX Study Shows Strong Performance with Durable Polymer Resolute Onyx DES in Head-to-Head Comparison with Biodegradable Polymer DES

DUBLIN and SAN DIEGO - September 22, 2018 - Investigators today unveiled new clinical data from the physician-initiated BIONYX study, representing the first all-comers analysis in nearly 2,500 patients comparing the safety and efficacy of the durable polymer Resolute Onyx(TM) drug-eluting stent (DP-DES) from Medtronic plc (NYSE: MDT) to the Orsiro biodegradable polymer stent (BP-DES). At one year, the study showed patients with coronary artery disease who were treated with Orsiro BP-DES received no clinical advantage compared to patients treated with the Resolute Onyx DP-DES, and Orsiro BP-DES demonstrated a higher rate of stent thrombosis.1 Published simultaneously in The Lancet, the results were presented today during a Late-Breaking Clinical Trial session at the 30th Transcatheter Cardiovascular Therapeutics conference (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

Enrolling approximately 2,500 real-world patients (71 percent with acute coronary syndrome), the BIONYX study had a primary composite endpoint of target vessel failure (TVF) at one-year and showed no statistically significant difference in outcomes for the Resolute Onyx DP-DES treated group (N=1,243) at 4.5 percent compared to 4.7 percent with the Orsiro BP-DES. However, notable differences were observed in significantly lower rates of definite or probable stent thrombosis (0.1 percent for Resolute Onyx compared to 0.7 percent with Orsiro DES) at one year (p = 0.01).

"Never before has a head-to-head stent trial assessed the new-generation durable polymer zotarolimus-eluting stent - the Resolute Onyx DES - which has thinner struts and improved visibility compared to its predecessor, the Resolute Integrity DES," said Prof. Clemens von Birgelen, M.D. Ph.D., co-director of the Department of Cardiology at Thoraxcentrum Twente, Professor of Cardiology at University of Twente in Enscheded, the Netherlands, principal investigator of the trial and presenter of the data at TCT. "The Resolute Onyx demonstrated excellent safety and efficacy that matched at one-year the results of a biodegradable polymer sirolimus-eluting stent with ultra-thin struts that showed excellent outcomes in previous head-to-head stent studies. The stent thrombosis data are promising, but should not be overestimated as we cannot exclude a play of chance."

The Resolute Onyx DES is coated with the proprietary BioLinx(TM)polymer, a bio-compatible and non-thrombogenic coating specifically designed for use on DES. Low rates of stent thrombosis have been observed in more than 70,000 real-world clinical study patients, with additional studies underway, including the global Medtronic Onyx ONE Month DAPT Program comprised of two studies designed to investigate safety following one-month of dual anti-platelet therapy (DAPT) discontinuation post-PCI. The Resolute Onyx DES offers the broadest size matrix available and is the first-and-only DES to feature Core Wire Technology which enables thinner struts and greater deliverability while maintaining structural strength and enhanced visibility.

"We have yet to see any meaningful clinical benefit with the introduction of biodegradable stent technologies," said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. "The Resolute Onyx DES has been shown to deliver excellent outcomes for a wide range of patients, and we are pleased to see that the combination of visibility, thin struts, conformability, and biocompatibility resulted in a very low stent thrombosis rate in this study."

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

-end-

1 Stent thrombosis was not a powered endpoint in the BIONYX Study. 

Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494

Ryan Weispfenning
Investor Relations
+1-763-505-4626





This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via Globenewswire

Nachrichten zu Medtronic PLC

  • Relevant
  • Alle
  • vom Unternehmen
  • Peer Group
  • ?

Um Ihnen die Übersicht über die große Anzahl an Nachrichten, die jeden Tag für ein Unternehmen erscheinen, etwas zu erleichtern, haben wir den Nachrichtenfeed in folgende Kategorien aufgeteilt:

Relevant: Nachrichten von ausgesuchten Quellen, die sich im Speziellen mit diesem Unternehmen befassen

Alle: Alle Nachrichten, die dieses Unternehmen betreffen. Z.B. auch Marktberichte die außerdem auch andere Unternehmen betreffen

vom Unternehmen: Nachrichten und Adhoc-Meldungen, die vom Unternehmen selbst veröffentlicht werden

Peer Group: Nachrichten von Unternehmen, die zur Peer Group gehören

Analysen zu Medtronic PLC

  • Alle
  • Buy
  • Hold
  • Sell
  • ?
16.10.2018Medtronic OverweightBarclays Capital
22.08.2018Medtronic HoldStifel, Nicolaus & Co., Inc.
13.08.2018Medtronic Strong BuyNeedham & Company, LLC
06.06.2018Medtronic BuyNeedham & Company, LLC
22.11.2017Medtronic HoldStifel, Nicolaus & Co., Inc.
16.10.2018Medtronic OverweightBarclays Capital
22.08.2018Medtronic HoldStifel, Nicolaus & Co., Inc.
13.08.2018Medtronic Strong BuyNeedham & Company, LLC
06.06.2018Medtronic BuyNeedham & Company, LLC
22.11.2017Medtronic HoldStifel, Nicolaus & Co., Inc.
01.06.2016Medtronic NeutralWedbush Morgan Securities Inc.
23.11.2012Medtronic holdDeutsche Bank Securities
22.11.2012Medtronic neutralCredit Suisse Group
22.11.2012Medtronic neutralJP Morgan Chase & Co.
21.11.2012Medtronic sector performRBC Capital Markets
22.08.2007Medtronic underweightMorgan Stanley
29.09.2006Update Kyphon Inc.: UnderweightMorgan Stanley

Um die Übersicht zu verbessern, haben Sie die Möglichkeit, die Analysen für Medtronic PLC nach folgenden Kriterien zu filtern.

Alle: Alle Empfehlungen

Buy: Kaufempfehlungen wie z.B. "kaufen" oder "buy"

Hold: Halten-Empfehlungen wie z.B. "halten" oder "neutral"

Sell: Verkaufsempfehlungn wie z.B. "verkaufen" oder "reduce"
mehr Analysen

+ 13% pro Jahr - So erzielen Sie höhere Renditen

Wie können Anleger mehr Rendite aus ihrem Depot holen ohne dabei höhere Risiken einzugehen? Im Online-Seminar erklärt der Finanz­mathematiker Michael Schnoor, wie es funktioniert.
Hier informieren und kostenlos anmelden
Anzeige
Anzeige
Börse Stuttgart Anlegerclub

Fünf deutsche Internet-Aktien, die Sie kennen sollten!

Das Gute liegt oft so nah. Heimische Internet-Unternehmen rollen den Markt auf. Im neuen Anlegermagazin erwartet Sie ein Special über deutsche Internet-Aktien, die Sie kennen sollten.
Kostenfrei registrieren und lesen!

Heute im Fokus

DAX geht tiefer aus dem Handel -- Dow nach Fed-Protokoll leichter -- Elon Musk kauft Tesla-Aktien -- Fresenius pessimistischer für Gesamtjahr -- Netflix schlägt Erwartungen -- IBM, FMC, Roche im Fokus

Investoren wollen Sanierung von Steinhoff nicht mit Klagen stören. "Boomwahrscheinlichkeit" in Deutschland bei knapp 35 Prozent. RIB Software beschließt kleinen Aktienrückkauf. EU genehmigt Verkauf von Praxair-Geschäften nach Japan. BVB-Aktie im Aufwind: 17-Jahres-Hoch. Experten rechnen mit anhaltend steigenden Anleiherenditen.

Die 5 beliebtesten Top-Rankings

Die weltweit größten Smartphone-Hersteller
Der Worldwide Quarterly Mobile Phone Tracker
So viel erhalten Bundesliga-Clubs durch Trikotsponsoring
Das Trikotsponsoring der Bundesliga 2018/2019
In diesen Städten leben die Superreichen
Welche Stadt ist besonders beliebt?
Automobilneuheiten-Messe
Neue Studien und Serienfahrzeuge
Best Global Brands 2018
Die Top 20 der wertvollsten Marken weltweit
mehr Top Rankings

Umfrage

Glauben Sie, dass Angela Merkel Anfang Dezember auf dem Parteitag der CDU als Parteichefin wiedergewählt wird?

Online Brokerage über finanzen.net

Das Beste aus zwei Welten: Handeln Sie für nur 5 Euro Orderprovision* pro Trade unmittelbar aus der Informationswelt von finanzen.net!
Zur klassischen Ansicht wechseln
Kontakt - Impressum - Werben - Pressemehr anzeigen
Top News
Beliebte Suchen
DAX 30
Öl
Euro US-Dollar
Bitcoin
Goldpreis
Meistgesucht
Lufthansa AG823212
Aurora Cannabis IncA12GS7
Fresenius Medical Care AG & Co. KGaA (FMC) St.578580
Netflix Inc.552484
Amazon906866
Wirecard AG747206
Fresenius SE & Co. KGaA (St.)578560
Deutsche Bank AG514000
Daimler AG710000
EVOTEC AG566480
Apple Inc.865985
TeslaA1CX3T
Deutsche Telekom AG555750
BVB (Borussia Dortmund)549309
BASFBASF11