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Lepu Medical Releases Updates of Clinical trial results of NewVas Stent in EuroPCR 2016
Date:2016-06-03


Lepu Medical recently attended EuroPCR 2016, a world leading course in interventional cardiovascular medicine that was held in Paris, France at the booth M41 from 17th to 20th May 2016, to promote our different products and production lines, and released the latest 6-month and 1-years follow-up results of NeoVas TM First-in-Man Study. 

On May 19, Dr. Yao-Jun Zhang, from Nanjing First Hospital, Nanjing Medical University reported the 6-month Angiographic, IVUS, OCT, 1-Year MSCT and Clinical Results of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients with de Novo Coronary Artery Lesion (NeoVas TM): the First-in-Man Study.



The LEPU MEDICAL NeoVas TM sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold, bioresorbable poly lactic add (PDLLA) coating carrier and contains the antiproliferative drug – Sirolimus. Like metal stents, placement of NeoVas TM bioresorbable stent restores blood flow and supports the vessel through healing process. But then it will be gradually resorb in the body when it’s no longer needed to prevent the potential drawbacks of using metal drug-eluting stents from happening, including predisposition to late stent thrombosis, prevention of late vessel adaptive or expansive remodeling, hindrance of surgical revascularization, and impairment of imaging with multislice CT.



The NeoVas TM First-in-Man Study is a prospective, two-center study which verified the feasibility, preliminary safety and efficacy of NeoVas TM initially in patients with de novo coronary lesion. 

Approximately 30 subjects were enrolled and received NeoVas TM treatment. Subjects will have clinical follow-up at 30, 180 and 270 days and at 1, 2, 3 and 5 years. The primary endpoint is target lesion failure (TLF) at 30 days follow-up. TLF is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization (iTLR).

The Angiographic Results can be divided into Intention-to-Treat Population and Per Protocal Set. Among those factors, minimum lumen diameter (MLD) slightly decreased from post-procedure to 6-month follow-up, which was also reflected in cumulative frequency (data not shown). A slight acute recoil at 6-month was 0.15mm. In addition, there was only one in-scaffold binary restenosis case, and late lumen loss (LLL) in scaffold was 0.26.


The IVUS results noted that mean vessel area remained unchanged in 6-month follow-up, and the mean lumen area slightly reduced from 8.69 to 8.22 mm2. Both scaffold volume obstruction and late percent recoil were quite low.


Similar results were found in 6-month OCT examinations and 1-year MSCT results. Proportion of covered struts in 6-month reached a very high point at 95.7%, with few incomplete strut apposition (0.58%). And area stenosis was 22.6%, which was acceptable. (data not shown)

As for 1-year clinical outcomes, no death was occurred and one case suffered the myocardial infarction (MI) while it’s not related to target vessel. One patient suffered target lesion revascularization (TLR) within 6-month. In total the 1-year TLF is 3.2%.



The present FIM Study of NeoVas TM Demonstrated the feasibility, preliminary, safety and efficacy of the novel bioresorbable scaffold NeoVas TM in patients with single de novo coronary lesions. And in the near future long-term imaging follow-up results will provide with more valuable information. More important, pivotal randomized trial is ongoing. Randomized Controlled Trial is a prospective, multicenter, single-blinded randomized study, which included Xience V stent as contrast set. Currently, Lepu Medical has completed a total of 560 patients enrollment and started the 30days to 5-year follow-up observation. Single-Arm Uncontrolled Registry Trial required by CFDA, enrolled 825 patients is also going on well

 

About EuroPCR 

EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading Course in interventional medicine.

EuroPCR is the flagship of all PCR educational events by size, but also by offering: it is the global forum for sharing within and between all interventional communities. The diversity of PCR communities is apparent in the various common denominators around which they form. Whether it is by interest, activity or generation, by disease track (from coronary intervention to heart failure), by nationality, by primary interest (CTO, invasive physiology, mitral repair, clinical research, bifurcation PCI, innovation), by practice: colleagues find each other here in Paris.


Taking place in Paris from 17-20 May, EuroPCR promises to keep pushing boundaries in education, setting the stage to present latest technologies, services and innovations to an eager 12,000+ members of the worldwide interventional cardiovascular community.


About Lepu Medical
Lepu Medical has gradually formed global sales and marketing capabilities since 2009. Today, Lepu has established two branches located in the Netherlands and Turkey, and one office in India. Taking these three countries as regional hubs, Lepu has developed its overseas sales & distribution network to approximate 80 countries, obtaining local registration in more than 24 countries. More than 35 products received CE certificate and 6 products got FDA approval.
 
Upholding “Forever innovation, Forever care” as its spirit, Lepu Medical dedicates to serve all medical personnel and patients that aiming to build the first class international brand on both products and services.
 
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SOURCE: Lepu Medical International Sales & Marketing Department
 

 
 
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