NVCN
| eröffnet am: | 07.09.16 09:43 von: | wennichdaswueste |
| neuester Beitrag: | 25.04.21 02:31 von: | Mariezuvga |
| Anzahl Beiträge: | 1152 | |
| Leser gesamt: | 184133 | |
| davon Heute: | 5 | |
bewertet mit 6 Sternen |
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01.09.17 19:39
#777
ermlitz
fasst alles bezahlt
und .........................und Neovasc bleibt der gemeinsame Erfinder des '964-Patents, eines der Patente in der Tiara ™ Patentfamilie, zusammen mit zwei Mitarbeitern von CardiAQ Valve Technologies, Inc., wobei beide Parteien die Freiheit haben, das Patent ohne Verpflichtung zur Lizenzgebühr zu verwenden das
01.09.17 20:23
#780
bjkrug
eher weniger...
kann mich aber grad nicht mit befassen...
Glaube aber, die haben den Rechtsstreit verloren!
Glaube aber, die haben den Rechtsstreit verloren!
01.09.17 20:39
#781
ermlitz
das stimmt #780
abbbber
........Zusammenfassend lässt sich sagen, dass Neovasc das vollständige Urteil über etwa 112 Millionen US-Dollar bezahlen muss, wovon rund 70 Millionen US-Dollar bereits in einem Treuhandkonto enthalten sind, wenn das Urteil nicht durch ein zusätzliches Berufungsverfahren geändert wird.
........Zusammenfassend lässt sich sagen, dass Neovasc das vollständige Urteil über etwa 112 Millionen US-Dollar bezahlen muss, wovon rund 70 Millionen US-Dollar bereits in einem Treuhandkonto enthalten sind, wenn das Urteil nicht durch ein zusätzliches Berufungsverfahren geändert wird.
01.09.17 21:15
#784
bjkrug
jau.
zzgl der nicht erfolgreiche EntwicklungStopp, der nicht genehmigt wurde :-).
Patente zu 100% bei Neovasc.
Montag mal abwarten
Patente zu 100% bei Neovasc.
Montag mal abwarten
12.09.17 16:24
#789
ermlitz
ähm
Neovasc Provides Tiara™ Clinical Update
Dienstag, 12.09.2017 13:05 von PR Newswire
PR Newswire
VANCOUVER, Sept. 12, 2017
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 12, 2017 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today provided an update on the study progress and clinical performance of the TiaraTM valve, a self-expanding mitral bioprosthesis for transcatheter implantation in patients with Mitral Regurgitation ("MR"), one of the most prevalent valvular heart diseases in western countries. MR is often severe and can lead to heart failure and death.
To date, 34 patients have been treated with the TiaraTM valve at ten different medical centers across the United States, Canada, Germany, Italy, Belgium, Switzerland and Israel. The technical success rate in these implantations is 31/34 or 91.1%. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases. All cause, 30-day mortality in the 33 patients who have reached 30 days post implant with TiaraTM is 12.1% (4/33). The remaining patient treated within the last 30 days is recovering well. To date, the longest surviving patient has passed 3.5 years post implant.
"Transcatheter implantation of the Tiara mitral valve resulted in immediate elimination of MR and improved the performance of the heart, without the need for any cardiac support device and with no procedural complications," commented Professor Dr. Ulrich Schafer, an Interventional Cardiologist from the Cardiology Department at the University Heart Center Hamburg and one of the CE Mark trial's principal investigators. "The results we see so far are very encouraging in this very sick and high-risk patient population. These patients with severe MR and severe heart failure tolerate the Tiara implantation procedure without any major issues, and most of them are discharged home 3-5 days after the valve implantation."
Implantations of the TiaraTM are being performed under 3 parallel clinical/investigational programs: 1) a European pivotal CE Mark trial, TIARA-II; 2) an FDA Early Feasibility trial, TIARA-I; and 3) compassionate use/special access treatment. To date, the Company has received regulatory approval in Italy, Germany and the UK to conduct the TIARA-II study at 10 centers (5 in Italy, 3 in Germany and 2 in the UK). The TIARA-II study, which is the primary focus of the Tiara program, is a 115 patient, non-randomized, prospective clinical study evaluating Tiara's safety and performance. It is expected that data from this study will be used to file for CE Mark approval.
In addition, the Company has recruited two new U.S. centers to participate in its TIARA-I study, and is actively recruiting in 4 centers in the U.S., 1 center in Belgium, and 3 centers in Canada. TIARA-I is an international, multicenter early feasibility study being conducted to assess the safety and performance of the Tiara™ mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation.
Upcoming Presentations
TiaraTM results and data continue to be presented at major medical conferences, including on September 9th, when Dr. Paulo Denti, principal investigator at San Raffaele Hospital, Milan, Italy presented a TiaraTM case example at CSI-UCSF 2017, a conference hosted by the CSI Foundation in association with the University of California, San Francisco (UCSF); and, on September 25th, Dr. Anson Cheung, a principal investigator of the TIARA-I study, will be presenting an update on the Neovasc TiaraTM program at PCR London Valves 2017 conference, an annual meeting of the European Association for Percutaneous Cardiovascular Interventions.
About Tiara™
Tiara™ is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients affected throughout Europe. TiaraTM is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws regarding the Company's plans and expectations to use data from the TIARA-II study to file for CE Mark approval and to continue to present TiaraTM results and data at major medical conferences. Words and phrases such as "expected", "continue" and "will", and similar words or expressions, are intended to identify these forward-looking statements. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, risks relating to the Company's litigation with CardiAQ, including the Company's ability to successfully appeal the validity of the awards as well as the ruling on inventorship, which create material uncertainty and which cast substantial doubt on the Company's ability to continue as a going concern; the substantial doubt about the Company's ability to continue as a going concern; risks relating to the Company's need for significant additional future capital and the Company's ability to raise additional funding; risks relating to claims by third parties alleging infringement of their intellectual property rights; the Company's ability to establish, maintain and defend intellectual property rights in the Company's products; risks relating to results from clinical trials of the Company's products, which may be unfavorable or perceived as unfavorable; the Company's history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company's ability to achieve or maintain expected levels of market acceptance for the Company's products, as well as the Company's ability to successfully build the Company's in-house sales capabilities or secure third-party marketing or distribution partners; the Company's ability to convince public payors and hospitals to include the Company's products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks associated with the extensive regulation of the Company's products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks associated with post-market regulation of the Company's products; health and safety risks associated with the Company's products and the Company's industry; risks associated with the Company's manufacturing operations, including the regulation of the Company's manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risk of animal disease associated with the use of the Company's products; risks relating to the manufacturing capacity of third-party manufacturers for the Company's products, including risks of supply interruptions impacting the Company's ability to manufacture its own products; risks relating to breaches of anti-bribery laws by the Company's employees or agents; risks associated with future changes in financial accounting standards and new accounting pronouncements; the Company's dependence upon key personnel to achieve the Company's business objectives; the Company's ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company's management systems and resources in periods of significant growth; risks associated with consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; the Company's ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; anti-takeover provisions in the Company's constating documents which could discourage a third party from making a takeover bid beneficial to the Company's shareholders; risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers; and risks relating to the influence of significant shareholders of the Company over the Company's business operations and share price. These risk factors and others relating to the Company are discussed in greater detail in the "Risk Factors" section of the Company's Annual Information Form and in the Company's Management's Discussion and Analysis of Financial Condition and Results of Operations (copies of which filings may be obtained at www.sedar.com or www.sec.gov, each of which are included in the Company's Annual Report on Form 40-F). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Neovasc Inc.
Neovasc Provides Tiara™ Clinical Update
Dienstag, 12.09.2017 13:05 von PR Newswire
PR Newswire
VANCOUVER, Sept. 12, 2017
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 12, 2017 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today provided an update on the study progress and clinical performance of the TiaraTM valve, a self-expanding mitral bioprosthesis for transcatheter implantation in patients with Mitral Regurgitation ("MR"), one of the most prevalent valvular heart diseases in western countries. MR is often severe and can lead to heart failure and death.
To date, 34 patients have been treated with the TiaraTM valve at ten different medical centers across the United States, Canada, Germany, Italy, Belgium, Switzerland and Israel. The technical success rate in these implantations is 31/34 or 91.1%. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases. All cause, 30-day mortality in the 33 patients who have reached 30 days post implant with TiaraTM is 12.1% (4/33). The remaining patient treated within the last 30 days is recovering well. To date, the longest surviving patient has passed 3.5 years post implant.
"Transcatheter implantation of the Tiara mitral valve resulted in immediate elimination of MR and improved the performance of the heart, without the need for any cardiac support device and with no procedural complications," commented Professor Dr. Ulrich Schafer, an Interventional Cardiologist from the Cardiology Department at the University Heart Center Hamburg and one of the CE Mark trial's principal investigators. "The results we see so far are very encouraging in this very sick and high-risk patient population. These patients with severe MR and severe heart failure tolerate the Tiara implantation procedure without any major issues, and most of them are discharged home 3-5 days after the valve implantation."
Implantations of the TiaraTM are being performed under 3 parallel clinical/investigational programs: 1) a European pivotal CE Mark trial, TIARA-II; 2) an FDA Early Feasibility trial, TIARA-I; and 3) compassionate use/special access treatment. To date, the Company has received regulatory approval in Italy, Germany and the UK to conduct the TIARA-II study at 10 centers (5 in Italy, 3 in Germany and 2 in the UK). The TIARA-II study, which is the primary focus of the Tiara program, is a 115 patient, non-randomized, prospective clinical study evaluating Tiara's safety and performance. It is expected that data from this study will be used to file for CE Mark approval.
In addition, the Company has recruited two new U.S. centers to participate in its TIARA-I study, and is actively recruiting in 4 centers in the U.S., 1 center in Belgium, and 3 centers in Canada. TIARA-I is an international, multicenter early feasibility study being conducted to assess the safety and performance of the Tiara™ mitral valve system and implantation procedure in high-risk surgical patients suffering from severe mitral regurgitation.
Upcoming Presentations
TiaraTM results and data continue to be presented at major medical conferences, including on September 9th, when Dr. Paulo Denti, principal investigator at San Raffaele Hospital, Milan, Italy presented a TiaraTM case example at CSI-UCSF 2017, a conference hosted by the CSI Foundation in association with the University of California, San Francisco (UCSF); and, on September 25th, Dr. Anson Cheung, a principal investigator of the TIARA-I study, will be presenting an update on the Neovasc TiaraTM program at PCR London Valves 2017 conference, an annual meeting of the European Association for Percutaneous Cardiovascular Interventions.
About Tiara™
Tiara™ is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an estimated four million in the U.S. with a similar number of patients affected throughout Europe. TiaraTM is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart surgery or use of a cardiac bypass machine.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws regarding the Company's plans and expectations to use data from the TIARA-II study to file for CE Mark approval and to continue to present TiaraTM results and data at major medical conferences. Words and phrases such as "expected", "continue" and "will", and similar words or expressions, are intended to identify these forward-looking statements. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. Many factors and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, risks relating to the Company's litigation with CardiAQ, including the Company's ability to successfully appeal the validity of the awards as well as the ruling on inventorship, which create material uncertainty and which cast substantial doubt on the Company's ability to continue as a going concern; the substantial doubt about the Company's ability to continue as a going concern; risks relating to the Company's need for significant additional future capital and the Company's ability to raise additional funding; risks relating to claims by third parties alleging infringement of their intellectual property rights; the Company's ability to establish, maintain and defend intellectual property rights in the Company's products; risks relating to results from clinical trials of the Company's products, which may be unfavorable or perceived as unfavorable; the Company's history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company's ability to achieve or maintain expected levels of market acceptance for the Company's products, as well as the Company's ability to successfully build the Company's in-house sales capabilities or secure third-party marketing or distribution partners; the Company's ability to convince public payors and hospitals to include the Company's products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks associated with the extensive regulation of the Company's products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks associated with post-market regulation of the Company's products; health and safety risks associated with the Company's products and the Company's industry; risks associated with the Company's manufacturing operations, including the regulation of the Company's manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risk of animal disease associated with the use of the Company's products; risks relating to the manufacturing capacity of third-party manufacturers for the Company's products, including risks of supply interruptions impacting the Company's ability to manufacture its own products; risks relating to breaches of anti-bribery laws by the Company's employees or agents; risks associated with future changes in financial accounting standards and new accounting pronouncements; the Company's dependence upon key personnel to achieve the Company's business objectives; the Company's ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company's management systems and resources in periods of significant growth; risks associated with consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; the Company's ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; anti-takeover provisions in the Company's constating documents which could discourage a third party from making a takeover bid beneficial to the Company's shareholders; risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers; and risks relating to the influence of significant shareholders of the Company over the Company's business operations and share price. These risk factors and others relating to the Company are discussed in greater detail in the "Risk Factors" section of the Company's Annual Information Form and in the Company's Management's Discussion and Analysis of Financial Condition and Results of Operations (copies of which filings may be obtained at www.sedar.com or www.sec.gov, each of which are included in the Company's Annual Report on Form 40-F). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
SOURCE Neovasc Inc.
12.09.17 16:25
#790
ermlitz
go
ogle übers
eovasc bietet Tiara ™ Klinische Aktualisierung
Dienstag, 12.09.2017 13:05 von PR Newswire
PR Newswire
VANCOUVER, Sept. 12, 2017
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 12, 2017 / PRNewswire / - Neovasc Inc. ("Neovasc" oder das "Unternehmen") (NASDAQ, TSX: NVCN) gab heute ein Update über den Studienfortschritt und die klinische Leistungsfähigkeit des TiaraTM-Ventils, Erweiterung der Mitral-Bioprothese für die Transkatheter-Implantation bei Patienten mit Mitral-Regurgitation ("MR"), einer der häufigsten Herzklappenerkrankungen in den westlichen Ländern. MR ist oft schwer und kann zu Herzinsuffizienz und Tod führen.
Bisher wurden 34 Patienten mit dem TiaraTM-Ventil an zehn verschiedenen medizinischen Zentren in den USA, Kanada, Deutschland, Italien, Belgien, der Schweiz und Israel behandelt. Die technische Erfolgsquote bei diesen Implantaten beträgt 31/34 oder 91,1%. In diesen technisch erfolgreichen Implantaten wurden paravalvuläre Leckmengen in 100% dieser Fälle als mild, spur oder fehlend gemeldet. Alle Ursache, 30-Tage-Mortalität bei den 33 Patienten, die 30 Tage nach Implantat mit TiaraTM erreicht haben, beträgt 12,1% (4/33). Der verbleibende Patient, der innerhalb der letzten 30 Tage behandelt wurde, erholt sich gut. Bis heute hat der längste überlebende Patient 3,5 Jahre nach Implantat vergangen
"Die Transkatheter-Implantation des Tiara-Mitralklappens führte zu einer sofortigen Eliminierung von MR und verbesserte die Herzlichkeit, ohne die Notwendigkeit einer Herzunterstützung und ohne prozedurale Komplikationen", kommentierte Professor Dr. Ulrich Schafer, ein Interventioneller Kardiologe der Kardiologie Abteilung des Universitäts-Herzzentrums Hamburg und einer der wichtigsten Ermittler der CE-Mark-Studie. "Die Ergebnisse, die wir bisher sehen, sind sehr ermutigend in dieser sehr kranken und gefährdeten Patientenpopulation. Diese Patienten mit schwerer MR und schwerer Herzinsuffizienz tolerieren das Tiara-Implantationsverfahren ohne größere Probleme, und die meisten von ihnen werden nach Hause 3-5 entlassen Tage nach der Ventilimplantation. "
Implantationen des TiaraTM werden unter 3 parallelen klinischen / Untersuchungsprogrammen durchgeführt: 1) ein europäisches Potenzial CE-Zeichen, TIARA-II; 2) eine FDA Early Machbarkeitsstudie, TIARA-I; und 3) mitfühlende Verwendung / spezielle Zugangsbehandlung. Bisher hat die Gesellschaft in Italien, Deutschland und Großbritannien die Zulassung erteilt, um die TIARA-II-Studie an 10 Zentren (5 in Italien, 3 in Deutschland und 2 in Großbritannien) durchzuführen. Die TIARA-II-Studie, die im Mittelpunkt des Tiara-Programms steht, ist eine 15 Patienten, eine nicht randomisierte, prospektive klinische Studie zur Bewertung von Tiaras Sicherheit und Leistung. Es wird erwartet, dass Daten aus dieser Studie verwendet werden, um für CE-Zeichen Genehmigung zu archivieren.
Darüber hinaus hat das Unternehmen zwei neue U.S.-Zentren angeworben, um an seiner TIARA-I-Studie teilzunehmen und aktiv in 4 Zentren in den USA, 1 Zentrum in Belgien und 3 Zentren in Kanada zu rekrutieren. TIARA-I ist eine internationale, multizentrische frühzeitige Machbarkeitsstudie, die durchgeführt wird, um die Sicherheit und Leistungsfähigkeit des Tiara ™ Mitralklappensystems und des Implantationsverfahrens bei chirurgischen Patienten mit hohem Risiko zu untersuchen, die unter einer schweren Mitralinsuffizienz leiden.
Kommende Präsentationen
TiaraTM Ergebnisse und Daten werden weiterhin auf den großen medizinischen Konferenzen präsentiert, darunter am 9. September, als Dr. Paulo Denti, Principal Investigator im San Raffaele Hospital, Mailand, Italien ein TiaraTM Fallbeispiel bei CSI-UCSF 2017 präsentierte, eine Konferenz, die von der CSI-Stiftung in Zusammenarbeit mit der University of California, San Francisco (UCSF); und am 25. September präsentiert Dr. Anson Cheung, ein Principal Investigator der TIARA-I-Studie, ein Update über das Neovasc TiaraTM-Programm auf der PCR London Valves 2017 Konferenz, ein jährliches Treffen der Europäischen Vereinigung für perkutane Herz-Kreislauf-Interventionen.
Über Tiara ™
Tiara ™ ist eine selbstexpandierende Mitral-Bioprothese, die speziell für die Behandlung von Mitralklappen-Regurgitation (MR) entwickelt wurde, indem das erkrankte Ventil ersetzt wird. Konventionelle chirurgische Behandlungen sind nur für etwa die Hälfte der MR-Patienten, die schätzungsweise vier Millionen in den USA mit einer ähnlichen Anzahl von Patienten in ganz Europa betroffen. TiaraTM wird im Herzen mit einem minimal-invasiven, transapischen Transkatheter-Ansatz ohne die Notwendigkeit einer offenen Herzchirurgie oder Verwendung einer Herz-Bypass-Maschine implantiert.
Über Neovasc Inc.
Neovasc ist ein Spezialist für medizinische Geräte, das Produkte für den schnell wachsenden Herz-Kreislauf-Markt entwickelt, herstellt und vermarktet. Zu den Produkten gehören der Neovasc Reducer ™ zur Behandlung von refraktärer Angina, der derzeit nicht in den USA zur Verfügung steht und seit 2015 in Europa und der Tiara ™ für die Transkatheterbehandlung der Mitralklappenerkrankung zur Verfügung steht Untersuchung in den Vereinigten Staaten, Kanada und Europa. Das Unternehmen verkauft auch eine Reihe fortgeschrittener biologischer Gewebeprodukte, die als Schlüsselkomponenten in Drittanbieter-Medizinprodukten einschließlich Transkatheter-Herzklappen verwendet werden. Weitere Informationen finden Sie unter www.neo
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eovasc bietet Tiara ™ Klinische Aktualisierung
Dienstag, 12.09.2017 13:05 von PR Newswire
PR Newswire
VANCOUVER, Sept. 12, 2017
NASDAQ, TSX: NVCN
VANCOUVER, Sept. 12, 2017 / PRNewswire / - Neovasc Inc. ("Neovasc" oder das "Unternehmen") (NASDAQ, TSX: NVCN) gab heute ein Update über den Studienfortschritt und die klinische Leistungsfähigkeit des TiaraTM-Ventils, Erweiterung der Mitral-Bioprothese für die Transkatheter-Implantation bei Patienten mit Mitral-Regurgitation ("MR"), einer der häufigsten Herzklappenerkrankungen in den westlichen Ländern. MR ist oft schwer und kann zu Herzinsuffizienz und Tod führen.
Bisher wurden 34 Patienten mit dem TiaraTM-Ventil an zehn verschiedenen medizinischen Zentren in den USA, Kanada, Deutschland, Italien, Belgien, der Schweiz und Israel behandelt. Die technische Erfolgsquote bei diesen Implantaten beträgt 31/34 oder 91,1%. In diesen technisch erfolgreichen Implantaten wurden paravalvuläre Leckmengen in 100% dieser Fälle als mild, spur oder fehlend gemeldet. Alle Ursache, 30-Tage-Mortalität bei den 33 Patienten, die 30 Tage nach Implantat mit TiaraTM erreicht haben, beträgt 12,1% (4/33). Der verbleibende Patient, der innerhalb der letzten 30 Tage behandelt wurde, erholt sich gut. Bis heute hat der längste überlebende Patient 3,5 Jahre nach Implantat vergangen
"Die Transkatheter-Implantation des Tiara-Mitralklappens führte zu einer sofortigen Eliminierung von MR und verbesserte die Herzlichkeit, ohne die Notwendigkeit einer Herzunterstützung und ohne prozedurale Komplikationen", kommentierte Professor Dr. Ulrich Schafer, ein Interventioneller Kardiologe der Kardiologie Abteilung des Universitäts-Herzzentrums Hamburg und einer der wichtigsten Ermittler der CE-Mark-Studie. "Die Ergebnisse, die wir bisher sehen, sind sehr ermutigend in dieser sehr kranken und gefährdeten Patientenpopulation. Diese Patienten mit schwerer MR und schwerer Herzinsuffizienz tolerieren das Tiara-Implantationsverfahren ohne größere Probleme, und die meisten von ihnen werden nach Hause 3-5 entlassen Tage nach der Ventilimplantation. "
Implantationen des TiaraTM werden unter 3 parallelen klinischen / Untersuchungsprogrammen durchgeführt: 1) ein europäisches Potenzial CE-Zeichen, TIARA-II; 2) eine FDA Early Machbarkeitsstudie, TIARA-I; und 3) mitfühlende Verwendung / spezielle Zugangsbehandlung. Bisher hat die Gesellschaft in Italien, Deutschland und Großbritannien die Zulassung erteilt, um die TIARA-II-Studie an 10 Zentren (5 in Italien, 3 in Deutschland und 2 in Großbritannien) durchzuführen. Die TIARA-II-Studie, die im Mittelpunkt des Tiara-Programms steht, ist eine 15 Patienten, eine nicht randomisierte, prospektive klinische Studie zur Bewertung von Tiaras Sicherheit und Leistung. Es wird erwartet, dass Daten aus dieser Studie verwendet werden, um für CE-Zeichen Genehmigung zu archivieren.
Darüber hinaus hat das Unternehmen zwei neue U.S.-Zentren angeworben, um an seiner TIARA-I-Studie teilzunehmen und aktiv in 4 Zentren in den USA, 1 Zentrum in Belgien und 3 Zentren in Kanada zu rekrutieren. TIARA-I ist eine internationale, multizentrische frühzeitige Machbarkeitsstudie, die durchgeführt wird, um die Sicherheit und Leistungsfähigkeit des Tiara ™ Mitralklappensystems und des Implantationsverfahrens bei chirurgischen Patienten mit hohem Risiko zu untersuchen, die unter einer schweren Mitralinsuffizienz leiden.
Kommende Präsentationen
TiaraTM Ergebnisse und Daten werden weiterhin auf den großen medizinischen Konferenzen präsentiert, darunter am 9. September, als Dr. Paulo Denti, Principal Investigator im San Raffaele Hospital, Mailand, Italien ein TiaraTM Fallbeispiel bei CSI-UCSF 2017 präsentierte, eine Konferenz, die von der CSI-Stiftung in Zusammenarbeit mit der University of California, San Francisco (UCSF); und am 25. September präsentiert Dr. Anson Cheung, ein Principal Investigator der TIARA-I-Studie, ein Update über das Neovasc TiaraTM-Programm auf der PCR London Valves 2017 Konferenz, ein jährliches Treffen der Europäischen Vereinigung für perkutane Herz-Kreislauf-Interventionen.
Über Tiara ™
Tiara ™ ist eine selbstexpandierende Mitral-Bioprothese, die speziell für die Behandlung von Mitralklappen-Regurgitation (MR) entwickelt wurde, indem das erkrankte Ventil ersetzt wird. Konventionelle chirurgische Behandlungen sind nur für etwa die Hälfte der MR-Patienten, die schätzungsweise vier Millionen in den USA mit einer ähnlichen Anzahl von Patienten in ganz Europa betroffen. TiaraTM wird im Herzen mit einem minimal-invasiven, transapischen Transkatheter-Ansatz ohne die Notwendigkeit einer offenen Herzchirurgie oder Verwendung einer Herz-Bypass-Maschine implantiert.
Über Neovasc Inc.
Neovasc ist ein Spezialist für medizinische Geräte, das Produkte für den schnell wachsenden Herz-Kreislauf-Markt entwickelt, herstellt und vermarktet. Zu den Produkten gehören der Neovasc Reducer ™ zur Behandlung von refraktärer Angina, der derzeit nicht in den USA zur Verfügung steht und seit 2015 in Europa und der Tiara ™ für die Transkatheterbehandlung der Mitralklappenerkrankung zur Verfügung steht Untersuchung in den Vereinigten Staaten, Kanada und Europa. Das Unternehmen verkauft auch eine Reihe fortgeschrittener biologischer Gewebeprodukte, die als Schlüsselkomponenten in Drittanbieter-Medizinprodukten einschließlich Transkatheter-Herzklappen verwendet werden. Weitere Informationen finden Sie unter www.neo
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24.10.17 12:26
#799
bjkrug
so langsam
müssten mal ein paar Sachen bzgl des Rechtsstreites veröffentlicht werden.
26.10.17 15:00
#800
bjkrug
bsx am montag...
http://investors.bostonscientific.com/events-and-presentations