25 Jan

iVascular Official Program Activities at LINC 2017

iVascular is pleased to announce that we will be exhibiting at LINC-2017 in Leipzig, January 24-27. We will be showcasing last updates of the on-going studies such as EFFFPAC with Luminor 35, LUMINOR REGISTRY and EVOLUTION at 6 months with self-expanded stent iVolution.

Please visit us at booth #17b.

We invite you to attend iVascular Official Program Activities:

  • Presentations:
Tuesday 24th ǀ Room 6- Speakers’ corner
13:05 – 13:10 LUMINOR registry: a real world experience with a new DEB in advanced limb ischemia V. Riambau
14:05 – 14:10 EffPac trial: Assessment of the effectiveness of DCB versus POBA in the SFA U. Teichgräber
14:20 – 14:25 First 6-month results in 75 patients in the EVOLUTION study: investigating the iVolution stent in femoropopliteal lesions M. Bosiers
Wednesday 25th ǀ Room 5- Global Expert Exchange Forum
10:58 – 11:04 New manufacturing process and stent design are key elements to improve clinical outcome. The iVascular example P. Goverde

 

  • Live cases:
Wednesday 25th ǀ Room 5- Global Expert Exchange Forum
08:00 – 10:10 Deep dive session: Lower limb interventions (part I) – aortoiliac, femoropopliteal, and new technologies for crossing and vessel preparation.

Moderators: C. Walker, K. Urasawa

Panel: M. Montero-Baker

Wednesday 25th ǀ Room 1- Main Arena 1
16:30 – 18:10 New concepts for complex femoropopliteal disease

Moderators: M. Bosiers, T. Ohki

Panel: S. Steiner, D. Choi, R. Langhoff, A. Micari, J. McKinsey, O. Iida

LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the „vascular patients” by integrating colleagues of different specialties who are performing endovascular interventions.

Share this
18 Jan

iVascular will take part in AsiaPCR/SingLIVE 2017 in Singapore.

iVascular will take part in AsiaPCR/SingLIVE 2017, held on 19-21 January 2017 in Singapore.

We invite you to visit us at booth #15 to know more about our new product NC xperience.

 We encourage you to attend the presentation of Dr. Simon Lo “PCI with the Angiolite DES: an OCT study, the ANCHOR trial” on 19th of January at 2.12pm at Room 2.

course_en_asia

AsiaPCR/SingLIVE is an interactive educational course focusing on interventional cardiology in the Asia-Pacific region.

Share this
17 Jan

iVascular will be exhibiting at CACVS-2017 in Paris, France

iVascular is pleased to announce that we will be exhibiting at the international interactive post graduate course – Controversies and Updates in Vascular Surgery (CACVS) for Vascular Surgeons, Cardiac Surgeons, Vascular Radiologists and Angiologists.

CACVS-2017 will be held from January 19th to 21st in Paris, France.

iVascular official program activities:

 19th of January from 14:30, ePoster presentation “New manufacturing process and stent design are key elements to improve clinical outcome. The iVascular SX stent example” by Dr Peter Goverde will be available at the exhibition hall.

21st of January at 16:31, Prof. Riambau will speak about LUMINOR REGISTRY: Changing the paradigm of DCB in BTK: encouraging new results in complex lesions (AUDITORIUM / LEVEL -1).

We look forward to seeing you at the booth #14.

Share this
16 Nov

iVascular announces today that NC Xperience – non-compliant dilatation catheter – has received CE mark approval.

The NC Xperience catheter is now fully available in Europe and other countries that recognize the CE mark.

NC Xperience is indicated for:

  • CTOs and calcified lesions, requiring high pressure inflations and optimized crossing profile
  • Stent post-dilatation for enhance stent apposition to the artery wall.

“The non-compliant NC Xperience catheter is on the edge of the coronary balloon technology, providing the best combination of low crossing profile with high rated burst pressure (RBP),” commented Lluis Duocastella, CEO of iVascular S.L.U. “With this last addition to our portfolio, iVascular is now providing a complete platform to most demanding interventional cardiologists, performing highly complex interventions”.

The NC Xperience catheter offers an extra-low profile, outstanding deliverability and trackability, together with high pressure compatibility . It is available in a wide range of balloon diameters from 2.00 mm up to 5.0 mm, with balloon lengths ranging from 6 mm up to 30 mm.

iVascular is a fast-growing company based in Barcelona that has developed exclusive technologies in a vertically integrated project to innovate and produce coronary and endovascular devices from basic raw materials to the final device or implant, including DCB, DES, SE nitinol stents, CoCr BMS, thrombus extractors and angioplasty balloons.

Share this
19 May

iVascular completes recruitment of patients for its ANCHOR clinical trial of the sirolimus eluting stent ANGIOLITE

iVascular S.L.U. is pleased to announce that the recruitment of patients for the ANCHOR clinical trial has been completed with 104 patients treated with the sirolimus eluting stent ANGIOLITE and first interim 3-month data has been presented at EuroPCR Congress 2016.

Coordinated by PI Dr. Josep Rodés-Cabau from Quebec Heart and Lung Institute, the objective of ANCHOR clinical trial is to perform a prospective assessment of feasibility, exploratory efficacy and clinical performance of the novel ANGIOLITE sirolimus-eluting stent utilizing intracoronary optical coherence tomography (OCT). 104 patients with de-novo lesion, including those with chronic stable angina, acute coronary syndrome (NSTEMI) or in the setting of elective PCI have been included. An adaptive design of the study has randomized patients to either 3-month or 6-month angiographic/OCT follow-up. Clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post PCI.

The interim analysis at 3-month follow-up shows the following OCT-measured results: out of a total of 5892 struts analyzed, 89.1% ± 19.0% of covered struts, with neointimal area obstruction of only 6.1% ± 8.6%. The incomplete strut apposition rate (ISA) is 0.97%. This OCT results are supported by angiographic values of LLL = 0.07 ± 0.23 mm and 0% binary restenosis.

As stated by PI Dr. Josep Rodés-Cabau, “The main purpose of ANCHOR trial is to confirm and broaden ANGIOLITE’s promising efficacy and safety results obtained in preclinical models. The results of ANCHOR trial will allow direct comparison to other already published studies applying DES in the same target vessels. First interim data at 3 months is showing a high rate of covered struts with minimal neointimal hyperplasia and a very low incidence of strut malapposition”

ANGIOLITE is a sirolimus (1,4 µg/mm2) eluting stent on a L605 CoCr platform with ultra-thin struts of 80 µm. The distal part of the catheter is coated with a proprietary durable hydrophilic coating to minimize friction and improve its trackability. Stent sizes comprise diameters from 2.0 to 4.5 mm and lengths from 9 to 39 mm. Combining extra low profile with effective proven drug eluting coating technology, it will contribute to procedure cost reduction.

Mr. Lluís Duocastella, CEO of iVascular, commented, “We have successfully implemented a new coating technology based on the deposition of nanodrops of sirolimus and a new fluoroacrylate polymer on the surface of a stent. We are able to generate a homogeneous multilayer coating that is showing promising outcomes in clinical phase. Efficacy and safety are optimized by enhancing coating mechanical endurance and an optimized drug release profile”.

ANGIOLITE is commercially available in all Europe and other markets where CE Mark approval can expedite the registration process.

iVascular is a fast growing company based in Barcelona that has developed exclusive technologies in a vertically integrated project to innovate and produce coronary and endovascular devices from basic raw materials to the final device or implant, including DCB, DES, SE nitinol stents, CoCr BMS, thrombus extractors and angioplasty balloons.

Share this
16 May

iVascular Receives CE Mark Approval for LUMINOR 18 Drug Eluting Balloon

iVascular S.L.U., is pleased to announce that the LUMINOR 18 Drug Eluting Balloon, has received CE (Conformité Européenne) Mark approval.

LUMINOR 18, which is 0.018 Guide Wire compatible, is added to the existing LUMINOR range (Luminor14 and Luminor35), to offer the only complete drug eluting balloon portfolio to physicians performing lower limb angioplasty. Combining extra low profile with effective proven drug eluting coating technology, it will contribute to procedure cost reduction.

Mr. Lluis Duocastella, CEO of iVascular S.L.U., commented, “ The CE mark approval of LUMINOR18 represents a key milestone for iVascular S.L.U. Our extensive range of products will contribute to providing better support and service to patients and physicians.”

As stated by Dr Koen DELOOSE (Dendermonde, Belgium), “the well tapered, perfectly visible LUMINOR18 has an ultra-low profile. It is 4F introducer sheath compatible in most sizes, which is a significant improvement in the Drug Eluting Balloons world.”

With this CE Mark approval, iVascular S.L.U. is preparing LUMINOR 18 to be commercially available in all Europe and other markets where CE Mark approval can expedite the registration process.

iVascular is a fast growing company based in Barcelona that has developed exclusive technologies in a vertically integrated project to innovate and produce coronary and endovascular devices from basic raw materials to the final device or implant, including DCB, DES, SE nitinol stents, CoCr BMS, thrombus extractors and angioplasty balloons.

Share this
06 May

Preliminary results of the multicenter Spanish registry in lower limb ischemia treated with iVascular’s luminor drug eluting balloon

Background

The Paclitaxel-eluting balloonluminor”, in its versions for 0.014″, 0.018″ and 0.035″ guidewires, is a coaxial catheter designed for percutaneous transluminal angioplasties of peripheral arteries (iliac, femoral, popliteal and below-the-knee).

The balloon is coated with an homogeneous mixture of Paclitaxel, a derivative of Taxol, and a  physiologically innocuous matrix as excipient. The drug dose is 3 µg/mm2 and is intended to avoid cellular proliferation (restenosis), consequently decreasing re-intervention rate (TLR – Target Lesion Revascularization).

The coating is applied using iVascular’s proprietary technology “Transfertech” based on a spray dosage system of drug nano-drops. The overall result is a thin multi-layer coating with micro-crystalline structure that enhances drug transfer to the arterial wall.

Luminor Registry is an observational, prospective and multicentre study with single-arm treatment for native stenotic or occlusive lesions or in-stent stenosis of the femoro-poplietal (FP) and below the knee (BTK) vessels. The objective is to evaluate the performance of luminor drug-eluting balloons in terms of primary patency and freedom of serious adverse events. A maximum of 250 Rutherford 2-5 cases will be recruited following an intention to treat basis.

Results

Since Q4 – 2014, 143 cases with 165 lesions (81 CTO and 84 stenosis, 7.2±5.8cm and 5.9±4.5cm long respectively) have been included and monitored. Injury locations were 101 FP, 36 BTK and 14 FP+BTK:

  • 7 of them were in-stent stenosis
  • 82 patients were classified as Rutherford 5 (57.3%)
  • Technical success was achieved in 99.7% of the cases
  • Bailout stenting was necessary in 13 lesions (7.8%)
  • The cumulative primary patency rate at 6 months was 85.3%
  • 96 patients accomplished 6 month follow-up. For them, 30-day-mortality was 1.4%, with 8 major amputations (8.3%) and 6 TLR (6.3%; freedom TLR of 93.7%)

Conclusions

Initial primary endpoints are encouraging, even in patients with highly severe ischemic status (Rutherford 5 in 57.3% of the cases). Interim and final results will be published in future reports.

Data reported by F. Acín (Hospital Universitario de Getafe), M. de Blas (Hospital Universitario de Donostia), M. Alonso (Hospital Universitario Central Asturias), A. Giménez-Gaibar (Hospital Parc Taulí), V. Riambau (Hospital Clínic de Barcelona), representing LUMINOR registry collaborators.

 

Share this

© 2015 iVascular SLU. All rights reserved. Legal Notice | Terms of use Developed by Aprop Marketing

We use cookies to guarantee the best experience in your navigation. If you continue browsing consider to accept the use of cookies. More information

ACEPTAR
Aviso de cookies