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CFDA also released the news about Venus A-valve's regulatory approval on its official website recently. Please refer to the following link for detailed information: http://www.sda.gov.cn/WS01/CL0051/172161.html?from=groupmessage&isappinstalled=0https://www.hao123.com/?tn=96895497_hao_pg Together with a growing economy and an aging population, heart diseases such as aortic stenosis are becoming more prevalent amongst the elderly population. Over the past decades, surgical aortic valve replacement (SAVR) procedures have been used to treat such diseases. However, the effectiveness of SAVR operations is limited due to complications and significant mortality risks, especially for older and higher risk patients. Venus Medtech's transcatheter aortic valve system, Venus A-valve, offers a less invasive treatment solution for inoperable and high-risk patients, who now can be treated through a minimally invasive procedure as opposed to the traditional open-heart surgery while on cardiopulmonary bypass. Given TAVR's minimally invasive nature, patients also make faster progress in post-operation recovery. The population over 75 years old in China is approximately 44 million, of which approximately 1.5 million suffer from severe aortic stenosis, and have not had effective treatment. The launch of the Venus A-valve brings about much improved prospects for these patients. China's first home-made TAVR valve Venus A-valve was successfully implanted in Fuwai Hospital on Sept. 10th, 2012. Professor Gao Ruilin spearheaded the clinical research efforts. As part of the 12th National Five-Year Plan for technological growth, the Venus A-valve registered study included 101 operative cases across leading institutions in China, including Fuwai Hospital, West China Hospital, The Second Affiliated Hospital Zhejiang University School of Medicine, Jiangsu Province Hospital and Rui Jin Hospital. In the study, implantation success rate was 95% and 30-day all-cause mortality was 5%. In the full analysis set, the incidence of composite events (all-cause mortality or severe stroke) at 12 months was 7.1%, on par with international trial results. Professor Gao Ruilin commented: "The Venus A-valve is better suited for the Chinese population and physiological characteristics, with a higher implant success rate, similar complication rates and lower 2-year mortality rate compared to earlier generation TAVR products. The approval of the Venus A-valve by the CFDA is a true blessing for Chinese patients, and a breakthrough in the cardiovascular medical device sector given this product has been approved in China earlier than any comparable imported devices. This makes history." When asked about the clinical performance of the Venus A-valve, Dr. Horst Sievert, Director of Frankfurt Cardiovascular Center, commented: "the product design is highly focused on precision, and the results are satisfactory. Overall, based on available data, the Venus A-valve is superior to global competing products, when applied on Chinese patients." Professor Xingdong Zhang, Scientist of biomaterials at National engineering Research Center for Biomaterials, gave praise to the tissue treatment technology of the Venus A-valve: "Venus-A valve's anti-calcification technology represents a significant development in the application of biological materials in the cardiovascular space, it greatly enhances the valve's durability, prolongs the valve's working life, and significantly improves the patient's experience." Ms. Nisa Leung, Managing Partner of Qiming Venture Partners, commented on Venus Medtech's recent achievements: "We really value the experience and professionalism of the team under the leadership of Mr. Eric Zi. With the launch of Venus A, we believe Venus Medtech will become a leading cardiovascular company in China, and will also open the door to compete in international markets!" Mrs. Stephanie Hui, Managing Director of Goldman Sachs (Asia) L.L.C., commented: "Being a first-to-market and innovative cardiovascular device, approved under CFDA's fast-track system, Venus A-valve is a pioneer in the space of interventional cardiology, and has set a good example for future innovation in treating cardiovascular diseases." When asked about his future strategy, Mr. Eric Zi, CEO of Venus Medtech said, "We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. My vision for Venus Medtech goes beyond TAVR, as we aim to become a leader in the structured heart space. Our CE mark study for the Venus Pulmonary valve has already started as of September 2016. Our global trial for the third generation TAVR device, which embodies pre-packaged, retrievable and embolic protection features, will begin around the end of 2017. Its success should help Venus Medtech further strengthen our position in the market, and gain traction on a more global scale."


Together with a growing economy and an aging population, heart diseases such as aortic stenosis are becoming more prevalent amongst the elderly population. Over the past decades, surgical aortic valve replacement (SAVR) procedures have been used to treat such diseases. However, the effectiveness of SAVR operations is limited due to complications and significant mortality risks, especially for older and higher risk patients. Venus Medtech's transcatheter aortic valve system, Venus A-valve, offers a less invasive treatment solution for inoperable and high-risk patients, who now can be treated through a minimally invasive procedure as opposed to the traditional open-heart surgery while on cardiopulmonary bypass. Given TAVR's minimally invasive nature, patients also make faster progress in post-operation recovery. The population over 75 years old in China is approximately 44 million, of which approximately 1.5 million suffer from severe aortic stenosis, and have not had effective treatment. The launch of the Venus A-valve brings about much improved prospects for these patients. China's first home-made TAVR valve Venus A-valve was successfully implanted in Fuwai Hospital on Sept. 10th, 2012. Professor Gao Ruilin spearheaded the clinical research efforts. As part of the 12th National Five-Year Plan for technological growth, the Venus A-valve registered study included 101 operative cases across leading institutions in China, including Fuwai Hospital, West China Hospital, The Second Affiliated Hospital Zhejiang University School of Medicine, Jiangsu Province Hospital and Rui Jin Hospital. In the study, implantation success rate was 95% and 30-day all-cause mortality was 5%. In the full analysis set, the incidence of composite events (all-cause mortality or severe stroke) at 12 months was 7.1%, on par with international trial results. Professor Gao Ruilin commented: "The Venus A-valve is better suited for the Chinese population and physiological characteristics, with a higher implant success rate, similar complication rates and lower 2-year mortality rate compared to earlier generation TAVR products. The approval of the Venus A-valve by the CDFA is a true blessing for Chinese patients, and a breakthrough in the cardiovascular medical device sector given this product has been approved in China earlier than any comparable imported devices. This makes history." When asked about the clinical performance of the Venus A-valve, Dr. Horst Sievert, Director of Frankfurt Cardiovascular Center, commented: "the product design is highly focused on precision, and the results are satisfactory. Overall, based on available data, the Venus A-valve is superior to global competing products, when applied on Chinese patients." Professor Xingdong Zhang, Scientist of biomaterials at National engineering Research Center for Biomaterials, gave praise to the tissue treatment technology of the Venus A-valve: "Venus-A valve's anti-calcification technology represents a significant development in the application of biological materials in the cardiovascular space, it greatly enhances the valve's durability, prolongs the valve's working life, and significantly improves the patient's experience." Ms. Nisa Leung, Managing Partner of Qiming Venture Partners, commented on Venus Medtech's recent achievements: "We really value the experience and professionalism of the team under the leadership of Mr. Eric Zi. With the launch of Venus A, we believe Venus Medtech will become a leading cardiovascular company in China, and will also open the door to compete in international markets!" Mrs. Stephanie Hui, Managing Director of Goldman Sachs (Asia) L.L.C., commented: "Being a first-to-market and innovative cardiovascular device, approved under CFDA's fast-track system, Venus A-valve is a pioneer in the space of interventional cardiology, and has set a good example for future innovation in treating cardiovascular diseases." When asked about his future strategy, Mr. Eric Zi, CEO of Venus Medtech said, "We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. My vision for Venus Medtech goes beyond TAVR, as we aim to become a leader in the structured heart space. Our CE mark study for the Venus Pulmonary valve has already started as of September 2016. Our global trial for the third generation TAVR device, which embodies pre-packaged, retrievable and embolic protection features, will begin around the end of 2017. Its success should help Venus Medtech further strengthen our position in the market, and gain traction on a more global scale." To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/venus-medtechs-tavr-device-is-approved-by-cfda-creating-a-new-era-of-interventional-cardiology-in-china-300447984.html


HANGZHOU, China, April 28, 2017 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc., announced on April 25th that its transcatheter aortic valve system - Venus A-valve - has been approved by China Food and Drug Administration ("CFDA") (registration no.: 20173460680) for sale in China. This marks the first-ever CFDA approved Transcatheter Aortic Valve Implantation ("TAVR, TAVI") device in China, and the official commercialization of the Venus A-valve in China. Venus A-valve - has been approved by China Food and Drug Administration (“CFDA”) CFDA also released the news about Venus A-valve's regulatory approval on its official website recently. Please refer to the following link for detailed information: http://www.sda.gov.cn/WS01/CL0051/172161.html?from=groupmessage&isappinstalled=0https://www.hao123.com/?tn=96895497_hao_pg Together with a growing economy and an aging population, heart diseases such as aortic stenosis are becoming more prevalent amongst the elderly population. Over the past decades, surgical aortic valve replacement (SAVR) procedures have been used to treat such diseases. However, the effectiveness of SAVR operations is limited due to complications and significant mortality risks, especially for older and higher risk patients. Venus Medtech's transcatheter aortic valve system, Venus A-valve, offers a less invasive treatment solution for inoperable and high-risk patients, who now can be treated through a minimally invasive procedure as opposed to the traditional open-heart surgery while on cardiopulmonary bypass. Given TAVR's minimally invasive nature, patients also make faster progress in post-operation recovery. The population over 75 years old in China is approximately 44 million, of which approximately 1.5 million suffer from severe aortic stenosis, and have not had effective treatment. The launch of the Venus A-valve brings about much improved prospects for these patients. China's first home-made TAVR valve Venus A-valve was successfully implanted in Fuwai Hospital on Sept. 10th, 2012. Professor Gao Ruilin spearheaded the clinical research efforts. As part of the 12th National Five-Year Plan for technological growth, the Venus A-valve registered study included 101 operative cases across leading institutions in China, including Fuwai Hospital, West China Hospital, The Second Affiliated Hospital Zhejiang University School of Medicine, Jiangsu Province Hospital and Rui Jin Hospital. In the study, implantation success rate was 95% and 30-day all-cause mortality was 5%. In the full analysis set, the incidence of composite events (all-cause mortality or severe stroke) at 12 months was 7.1%, on par with international trial results. Professor Gao Ruilin commented: "The Venus A-valve is better suited for the Chinese population and physiological characteristics, with a higher implant success rate, similar complication rates and lower 2-year mortality rate compared to earlier generation TAVR products. The approval of the Venus A-valve by the CFDA is a true blessing for Chinese patients, and a breakthrough in the cardiovascular medical device sector given this product has been approved in China earlier than any comparable imported devices. This makes history." When asked about the clinical performance of the Venus A-valve, Dr. Horst Sievert, Director of Frankfurt Cardiovascular Center, commented: "the product design is highly focused on precision, and the results are satisfactory. Overall, based on available data, the Venus A-valve is superior to global competing products, when applied on Chinese patients." Professor Xingdong Zhang, Scientist of biomaterials at National engineering Research Center for Biomaterials, gave praise to the tissue treatment technology of the Venus A-valve: "Venus-A valve's anti-calcification technology represents a significant development in the application of biological materials in the cardiovascular space, it greatly enhances the valve's durability, prolongs the valve's working life, and significantly improves the patient's experience." Ms. Nisa Leung, Managing Partner of Qiming Venture Partners, commented on Venus Medtech's recent achievements: "We really value the experience and professionalism of the team under the leadership of Mr. Eric Zi. With the launch of Venus A, we believe Venus Medtech will become a leading cardiovascular company in China, and will also open the door to compete in international markets!" Mrs. Stephanie Hui, Managing Director of Goldman Sachs (Asia) L.L.C., commented: "Being a first-to-market and innovative cardiovascular device, approved under CFDA's fast-track system, Venus A-valve is a pioneer in the space of interventional cardiology, and has set a good example for future innovation in treating cardiovascular diseases." When asked about his future strategy, Mr. Eric Zi, CEO of Venus Medtech said, "We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. My vision for Venus Medtech goes beyond TAVR, as we aim to become a leader in the structured heart space. Our CE mark study for the Venus Pulmonary valve has already started as of September 2016. Our global trial for the third generation TAVR device, which embodies pre-packaged, retrievable and embolic protection features, will begin around the end of 2017. Its success should help Venus Medtech further strengthen our position in the market, and gain traction on a more global scale." Photo - https://photos.prnasia.com/prnh/20170428/1837794-1


Die Venus A-Valve ist die erste in China produzierte TAVR-Klappe und wurde am 10. September 2012 im Fuwai Hospital mit Erfolg implantiert. Professor Gao Ruilin leitete die klinische Forschung. Im Zuge des 12. nationalen Fünfjahresplans für technologisches Wachstum nahm die offizielle Studie der Venus A-Valve 101 Operationsfälle in führenden Institutionen in China auf, darunter in Fuwai Hospital, West China Hospital, The Second Affiliated Hospital Zhejiang University School of Medicine, Jiangsu Province Hospital und Rui Jin Hospital. In der Studie betrug die Erfolgsrate der Implantation 95 %. Die Sterblichkeit nach 30 Tagen aus allen Gründen betrug 5 %. In der vollständigen Analyse betrug das einschlägige Vorkommen (Sterblichkeit aus allen Gründen oder schwerer Herzanfall) nach 12 Monaten 7,1 %, was internationalen Studienergebnissen entspricht.


Gao S.,Zhejiang University | Li J.,Fudan University | Jiang C.,Fudan University | Hong B.,The Second Affiliated Hospital | Hao B.,Zhejiang University
Drug Design, Development and Therapy | Year: 2015

A gene drug delivery system for glioma therapy based on transferrin (Tf)-modified polyamidoamine dendrimer (PAMAM) was prepared. Gene drug, tumor necrosis factor-related apoptosis-inducing ligand (hTRAIL)-encoding plasmid open reading frame (pORF-hTRAIL, Trail), was condensed by Tf-modified PAMAM to form nanoparticles (NPs). PAMAM-PEG-Tf/DNA NPs showed higher cellular uptake, in vitro gene expression, and cytotoxicity than PAMAM-PEG/DNA NPs in C6 cells. The in vivo targeting efficacy of NPs was visualized by ex vivo fluorescence imaging. Tf-modified NPs showed obvious glioma-targeting trend. Plasmid encoding green fluorescence protein (GFP) was also condensed by modified or unmodified PAMAM to evaluate the in vivo gene expression level. The PAMAM-PEG-Tf/plasmid encoding enhanced green fluorescence protein (pEGFP) NPs exhibited higher GFP expression level than PAMAM-PEG/pEGFP NPs. TUNEL assay revealed that Tf-modified NPs could induce much more tumor apoptosis. The median survival time of PAMAM-PEG-Tf/Trail-treated rats (28.5 days) was longer than that of rats treated with PAMAM-PEG/Trail (25.5 days), temozolomide (24.5 days), PAMAM-PEG-Tf/pEGFP (19 days), or saline (17 days). The therapeutic effect was further confirmed by magnetic resonance imaging. This study demonstrated that targeting gene delivery system had potential application for the treatment of glioma. © 2016 Gao et al.


Peng Y.,The Second Affiliated Hospital
Zhongguo zhen jiu = Chinese acupuncture & moxibustion | Year: 2011

To generalize the application of Tuina in treating infantile diseases and evaluate the validity and safety of Tuina. By a multicentre randomized controlled study, 240 patients were randomly divided into an observation group (n = 180) and a control group (n = 60). The observation group was treated by tonifying Pijing and clarifying Dachangjing, and Tuina on Lanmen, Qi, Fu Shangqijiegu, Guiwei and Zusanli (ST 36), etc. Banmen and Sanguan were used as the supplementary point according to the syndrome differentiation. The control group was treated by oral administration of Smecta. After 5 day treatments, Chinese syndrome score and the clinical effect were evaluated. After the third and fifth treatment, the Chinese syndrome score of both groups descended obviously. The decline of the observation group was superior to that of the control group (all P < 0.01). The cured rate of 75.6% (136/180) in the observation group was better than 21.7% (13/60) in the control group (P < 0.001). The clinical cured rate of 95.0% (171/180) according to Chinese syndrome score in the observation group was better than 58.3% (35/60) in the control group (P < 0.001). There was no adverse reaction in both groups. Infantile Tuina has a better therapeutic effect in the treatment of acute infantile diarrhea than oral administration of Smecta.


Wu T.-Y.,The Second Affiliated Hospital | Zhang T.-H.,The First Affiliated Hospital | Qu L.-M.,The Second Affiliated Hospital | Feng J.-P.,The Second Affiliated Hospital | And 5 more authors.
International Journal of Clinical and Experimental Pathology | Year: 2014

MiRNAs are small, noncoding RNA molecules that act as posttranscriptional regulators of gene expression and function as important regulators in cancer-related processes. The miR-19a is overexpressed in various cancers and has been causally related to cellular proliferation and growth. To determine whether miR-19a plays a role in laryngeal squamous cell carcinoma (LSCC), we used quantitative real time PCR to detect miR-19a expression in LSCC tissues. We found that miR-19a is overexpressed in LSCC and correlated with neck nodal metastasis, poor differentiation and advanced stage. Statistical analysis suggests that higher level of miR-19a was associated with reduced overall survival. In vitro functional study showed that inhibition of miR-19a by antisense oligonucleotides (ASO) led to apoptosis and reduction of cell proliferation in LSCC cells. Furthermore, growth of LSCC xenograft tumors was significantly suppressed by repeated injection of ASO-miR-19a lentivirus. The TUNEL stain and transmission electron microscopy also detected increased apoptotic cells in ASO-miR-19a treated LSCC xenografts. In addition, both realtime PCR and western blot showed ASO-miR-19a can upregulate TIMP-2 expression and this suggests miR-19a is related with TIMP-2 pathway in LSCC cells. Taken together, these data suggest that miR-19a plays an oncogenic role in the progression of LSCC, and may serve as a biomarker or therapeutic target for patients with LSCC.


Xie J.,the Affiliated Sir Run Run Shaw Hospital | Lv R.,the Affiliated Sir Run Run Shaw Hospital | Yu L.,the Second Affiliated Hospital | Huang W.,the First Affiliated Hospital
Journal of Surgical Research | Year: 2010

Background: Hydroxyethyl starch (HES) is one of the most frequently used plasma substitutes, and could modulate inflammatory response in sepsis. Our aim of this study was to investigate the mechanism of the effect of HES 130/0.4 by studying plasma levels of inflammatory cytokines, nuclear factor-κB (NF-κB) activation, and Toll-like receptors (TLRs) expression in peripheral monocytes during polymicrobial sepsis. Materials and Methods: Rats with sepsis induced by cecal ligation and puncture (CLP) were treated with HES130/0.4 (7.5, 15, or 30 mL/kg, intravenously); then, rat plasma and monocytes were isolated from blood 5 h later. The plasma level of cytokines (tumor necrosis factor [TNF]-α and interleukin [IL]-6), NF-κB activity, and mRNA and protein levels of TLRs (TLR2 and TLR4) in peripheral blood monocytes were determined by enzyme-linked immunosorbent assay, electrophoretic mobility shift assay, reverse transcription-polymerase chain reaction, and Western blotting, respectively. Results: HES130/0.4 dose-dependently reduced the plasma level of TNF-α and IL-6 in rats with sepsis. HES130/0.4 also significantly inhibited NF-κB activation, and TLRs mRNA and protein levels in peripheral monocytes. Conclusion: During sepsis, HES130/0.4 can down-regulate the inflammatory response, possibly through inhibition of the TLRs/NF-κB signaling pathway, and could be one more appropriate plasma substitute in sepsis. © 2010 Elsevier Inc. All rights reserved.


Liu L.,Nanjing Medical University | Jia F.,Health 123 | Yuan G.,Nanjing Medical University | Chen Z.,Nanjing Medical University | And 3 more authors.
Psychiatry Research | Year: 2010

The aim of this study is to profile the peripheral biomarkers (tyrosine hydroxylase, TH; interleukin-1β, IL-1β; and tumor necrosis factor-α, TNF-α) for schizophrenia and explore their relations with clinical symptoms. Thirty-nine patients with schizophrenia were evaluated using the Positive and Negative Syndrome Scale (PANSS), and 25 siblings and 30 normal healthy subjects were used as controls. The mRNA expression levels of TH, IL-1β and TNF-α in peripheral blood mononuclear cells, as determined with semi-quantitative reverse transcription-polymerase chain reaction, were all significantly increased in both patients (3-fold) and siblings (2-fold) as compared with normal control. Both IL-1β and TNF-α were significantly correlated with scores on the general psychopathology subscale of the PANSS. A significant positive correlation between IL-1β and TH expression was found in both sibling and normal controls, but not in patients, while a positive correlation between IL-1β and TNF-α was significant in all the groups. These results suggest that TH, IL-1β and TNF-α are overexpressed in the peripheral blood mononuclear cells of schizophrenia patients, perhaps due to the hereditary factors. IL-1β and TNF-α may influence the symptoms of schizophrenia in the cognition dysfunction and anxiety/depression domains of the PANSS. © 2008 Elsevier Ireland Ltd. All rights reserved.


Qin W.B.,The Second Affiliated Hospital
Zhonghua nan ke xue = National journal of andrology | Year: 2013

To study the changes in the activities of carbon monoxide (CO) and heme oxygenase 2 (HO-2) in ED rats with hyperhomocysteinemia (HHcy). This study included 40 male Wistar rats weighing 280 - 310 g, 10 as normal controls (group A). HHcy models were made in the other 30 by giving 3% methionine for 4 weeks, and then divided into groups B, C and D. The rats in group B continued to be fed with 3% methionine, those in group C were treated with betaine hydrochloride, and those in group D were given zinc porphyrin IX at 45 micromol per kg per d. Penile erections of the rats were recorded, and 4 weeks later, all were killed for determination of the levels of homocysteine (Hcy) in the blood plasma and the activities of CO and HO-2 in the corpus cavernosum of the penis. The level of plasma Hcy, penile erection frequency and the content of CO in the corpus cavernosum were (12.55 +/- 0.82) micromol/L, (1.88 +/- 0.05) times and (10.55 +/- 1.73) micromol/L in group A, the Hcy level significantly higher while the penile erection frequency and CO content remarkably lower than in group B ([25.01 +/- 0.94] micromol/L, [0.70 +/- 0.05] times and [9.51 +/- 1.52] micromol/L, P < 0.05 or P < 0.01), with a negative correlation between the level of Hcy and that of CO and HO-2 (P < 0.01). Compared with group B, the three parameters were all significantly increased in C ([14.37 +/- 0.47] micromol/L, [1.18 +/- 0.08] times and [10.36 +/- 1.56] micromol/L, all P < 0.05 or P < 0.01). Decreased expressions of CO and HO-2 in the corpus cavernosum of the penis may result in ED in HHcy rats. Betaine can reduce the Hcy level in the blood plasma and CO content in the corpus cavernosum, which might be one of the mechanisms of its action on ED with HHcy.

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