12 Jan

Oceanus 35, PTA balloon dilatation catheter receives CE Mark Approval for new catheter length of 200 cm.

Barcelona, December 22th, 2017- Oceanus 35, PTA balloon dilatation catheter receives CE Mark Approval for new catheter length of 200 cm.

iVascular is pleased to announce that its Oceanus 35 PTA balloon dilatation catheter has received CE mark approval for its new usable catheter length of 200cm. With this, iVascular offers a complete portfolio including the lengths 80cm, 140cm and now 200 cm. Oceanus 35 is the only PTA balloon catheter in the market that offers such useful catheter length.

Oceanus 35 is designed for dilation of stenosis located in the renal, iliac, femoral, popliteal and infrapopliteal arteries, and for the treatment of obstructive arteriovenous dialysis fistulae, native or synthetic.

“With this new catheter length, iVascular is proud to further expand our complete portfolio for the treatment of endovascular diseases. We aim to adapt quickly to the markets and to offer solutions that will satisfy the physician’s needs”. – said Lluis Duocastella, CEO of iVascular.

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18 Dec

Luminor DCB received approval for commercialization in New Zealand

Barcelona, December 18th, 2017- Luminor DCB has received approval for commercialization in New Zealand.

IVascular is pleased to announce that the Luminor Drug Coated Balloon (DCB) indicated for peripheral arteries, has received approval for commercialization in New Zealand.

Luminor is a Paclitaxel Coated Balloon specifically designed for dilatation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial. It is also indicated for stent postdilatation in the peripheral vascular system.

Its extra low crossing profile combined with TransferTechTM, iVascular proprietary technology for drug release, have demonstrated Luminor DCB efficacy in several clinical studies.

The EFFPAC Randomized Controlled Study (RCT) enrolled 171 patients at 11 German centers who were randomized to treatment with either the Luminor DCB or Plain Old Balloon Angioplasty (POBA). The comparison with other published RCTs, underlined that Luminor DCB demonstrates higher efficacy than most other available DCBs.

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05 Dec

iVascular starts partnership with TD Medical.

Barcelona, December 5th, 2017- iVascular starts partnership with TD Medical.

In September of this year, TD Medical announced that in 2018 they will become exclusive distributors of iVascular in Netherlands. TD Medical stated “IVascular fully fits our objectives. They offer us the space to adapt to the dynamic changes in Dutch healthcare. This offers many perspectives for our customers”.

As of 1st January 2018, their team will introduce iVascular products to the market. Their current customers will shortly be informed about the details of this new partnership.

TD Medical is a highly experienced Distribution Organization of Medical Products based in Eindhoven, The Netherlands. Since 1982, TD Medical has been a pioneer in multiple new innovative technologies in the Dutch Market. TD Medical is active and specialized in the Cardiovascular, Endovascular and Vascular disciplines.

Over the past years, their track record has become impressive with significant successes due to full market knowledge and long-lasting relationships with their customers and business partners. TD Medical is committed to the quality system NEN-EN-ISO 9001.

“iVascular is very pleased with this new collaboration. We believe that the Dutch market has a lot of potential. TD Medical is a very strong and highly committed company, we are convinced that this partnership is a great step for both companies”. – said Lluis Duocastella, CEO of iVascular S.L.U.

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04 Dec

Oceanus 14 Pro, PTA balloon catheter receives CE Mark Approval

Barcelona, December 4th, 2017- Oceanus 14 Pro, PTA balloon catheter receives CE Mark Approval.

iVascular is pleased to announce the release of the new Oceanus 14 Pro PTA balloon catheter, which has received CE Mark Approval to dilate stenoses in femoral, popliteal, and infrapopliteal arteries, and to treat obstructive lesions in arteriovenous dialysis fistulae.

Oceanus 14 Pro has been specifically elaborated to adapt to the market needs. Beyond its exceptional crossing profile and size range, including ultra-small diameters (1.25mm and 1.5mm) and lengths (10mm and 15mm), it is the only PTA catheter that adapts its number and type of radiopaque markers for enhanced visibility, flexibility and trackability:

1 tungsten radiopaque marker for the smallest and shortest balloons
2 tungsten radiopaque markers for smaller diameters and lengths over 20mm.
2 metallic radiopaque markers for other references.

“We are proud to bring to market the latest technology of PTA catheter. Our goal is to further develop technologies that will contribute to better long term clinical outcomes.” – said Lluis Duocastella, CEO of iVascular S.L.U.

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29 Sep

The T.I.N.T.I.N. trial evaluating the combined therapy of Luminor DCB and iVolution SX stent

Barcelona, September 25th, 2017 – iVascular S.L.U. has announced the initiation of the T.I.N.T.I.N. trial, evaluating the combined therapy of Luminor drug coated balloon (DCB) and iVolution self-expandable stent.

T.I.N.T.I.N. study is prospective, investigator-initiated, non-randomized, multi-center trial, investigating the 12 months safety and efficacy of combined Luminor DCB and iVolution self-expandable stent in TASC C and D femoropopliteal atherosclerotic lesions.

“Both Luminor and iVolution have already demonstrated their safety and efficacy in previous studies” stated Lluis Duocastella, CEO of iVascular S.L.U. “T.I.N.T.I.N. trial is the following step to prove their combined benefit for the patient with the most complex lesions”.

Dr. Koen Deloose (AZ Sint Blasius Dendermonde, Belgium), is the T.I.N.T.I.N. trial principal investigator. He has enrolled the 1st two patients on September 22nd. “We are excited to drive the first multicenter study evaluating the dual therapy DCB + BMS in real life TASC C and D lesions. Performing this with a drug eluting balloon that has shown the best results in a RCT as of today, and a self-expandable stent that has proven its efficacy in EVOLUTION trial, we expect outstanding results in the most challenging SFA lesions” declared Dr. Deloose.

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21 Sep

Luminor 14m has received the Canadian Medical Device License

Barcelona, September 21th, 2017 – iVascular S.L.U. has announced that Luminor 14m, the Drug Coated Balloon (DCB) indicated for below the knee BTK arteries, has received the Canadian Medical Device License (MDL).
Luminor 14m is a Paclitaxel Coated Balloon specifically designed for BTK indications, thanks to its extra low crossing profile combined with TransferTechTM, iVascular proprietary technology for drug release.

Lluis Duocastella, CEO of iVascular S.L.U., asserted: “The Luminor 14m MDL represents a key milestone for iVascular on the Canadian market. It opens a new horizon for our Endovascular product portfolio and will provide Canadian patients and physicians with the latest technology available to treat Critical Limb Ischemia.”

Earlier this week, the clinical data of Luminor DCB was presented during CIRSE 2017 in Copenhagen. EFFPAC Randomized Controlled Study (RCT) enrolled 171 patients at 11 German centers who were randomized to treatment with either the Luminor DCB or PTA. The comparison with other published RCTs, underlined that Luminor DCB demonstrates higher efficacy than most other available DCBs.

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20 Sep

iVascular SLU received approval for selling its coronary and peripheral products in India

Barcelona, September 20th, 2017 – iVascular SLU announced today that it has received approval for selling its coronary and peripheral products in India.

Indian medical devices market is the 4th largest in Asia and part of the global top 20.

“iVascular product portfolio was created with the latest technologies to improve patient’s outcomes and provide physicians with the solution for the challenges that they’ve meet daily. We are excited to expand our presence furthermore into Asian market”, said Lluis Duocastella, iVascular CEO.

Coronary drug eluting stent (DES), coronary Drug Coated Balloon (DCB), as well as peripheral DCB and stents are now available for sale on the Indian subcontinent:

  • Angiolite – coronary drug-eluting stent featuring exclusive coating nanotechnology “TransferWise”, that yields a multilayer thin biocompatible coating. The Safety and Efficacy of Angiolite DES for the treatment of patients with de novo lesions are confirmed by the OCT study – ANCHOR. Results of the ANCHOR study were published by Dr. Rishi Puri Quebec Heart and Lung Institute (IUCPQ), UL, Canada et al online ahead of print in Catheterization and Cardiovascular Interventions.
  • Essential, coronary DCB and Luminor, peripheral DCB, with TransferTechTM, iVascular proprietary coating nanotechnology, that guarantees drug’s stability, prevents from particles loss during navigation, and enhances fast and complete paclitaxel transfer to the vessel wall. EFFPAC Randomized Controlled Study with Luminor DCB demonstrates highly significant efficacy vs POBA. As stated by Prof. Ulf Teichgräber (Jena, Germany): “These incomparable outcomes are the result of the innovative coating technology of Luminor DCB, which is shown not only in the patency, LLL and TLR data, but also in significant improvement of patients’ clinical status”.
  • iVolution, an open-cell, self-expanding (SE) nitinol stent indicated for femoral and popliteal arteries
  • Restorer, a CoCr peripheral stent system, indicated for peripheral arteries

 

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18 Sep

iVascular EffPAC 6 Months Outstanding Data Presented at CIRSE 2017 DCB Session

Copenhagen – September 18, 2017 – iVascular SLU data announced today, demonstrate the efficacy of the Luminor drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The 6 months results from the full clinical cohort of the EffPAC randomized study were presented in the DCB session at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2017 conference in Copenhagen.

EffPAC Randomized Study 
Professor Ulf Teichgräber, M.D., director of the Departement of Radiology of the University Hospital Jena, Germany, presented the new, primary endpoint late lumen loss and the clinical six-months results from the full cohort of the EffPAC Randomized Control Study, demonstrating the effectiveness of Luminor DCB versus POBA in the SFA.

Primary and secondary endpoints were achieved with high statistical significance:

  • Primary endpoint revealed a late lumen loss (LLL) of 0.14mm in the DCB group vs 1.06mm in the POBA group (p<0.001).
  • Target Lesions Revascularization (TLR) was 1.3% (DCB) vs 17.1% (POBA) (p<0.001).
  • Primary Patency (PP) was 94.7% (DCB) vs 75.0% (POBA) (p<0.001).
  • Rutherford stages were overall improved for 85.2% patients (DCB) vs 75.0% (POBA) (p=0.021), and by 3 stages for 44.6% patients (DCB) vs 27.8% (POBA)

There was no amputation nor any product related adverse event in the DCB group.

The comparison with other published RCTs, underlined that Luminor DCB demonstrates higher efficacy than most other available DCBs. As stated by Prof. Ulf Teichgräber “These incomparable outcomes are the result of the innovative coating technology of Luminor DCB, which is shown not only in the patency, LLL and TLR data, but also in significant improvement of patients’ clinical status”.

The EffPAC RCT enrolled 171 patients at 11 German centres who were randomized to treatment with either the Luminor DCB or PTA. The 6 months data includes a total of 153 patients (77 DCB and 76 PTA).

EffPAC results are reinforcing the positive outcomes of the LUMINOR Registry” said Lluis Duocastella, CEO of iVascular SLU. “We are proud to continue to innovate and provide physicians with the latest technology to improve patients‘ outcomes”.

About Luminor Drug-Coated Balloon

Luminor is a paclitaxel coated balloon with an innovative and proprietary coating, using unique nanotechnology for minimized drug loss during navigation and enhanced delivery to the artery wall. Full range is available with 0.014”, 0.018” and 0.035” guidewire compatibility, providing ultra-low profile and fast deflation time.

Luminor DCB received the CE (Conformité Européenne) Mark in 2013 to treat superficial femoral, popliteal and infrapopliteal arteries. It is available in more than 50 countries. Pre-clinical study, as well as LUMINOR registry, have already demonstrated safety and efficacy in complex lesions.

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30 Aug

iVascular & Braile to partner to develop structural heart solutions

June 19th, 2017

iVascular S.L.U. and Braile Biomedica are pleased to announce that they have entered into a joint-venture agreement, to develop innovative structural heart solutions.

The new entity, based in Barcelona (Spain), will be managed by Mrs. Patricia Braile, CEO of Braile Biomedica, as President, and by Mr. Lluis Duocastella, CEO of iVascular SLU, as CEO.

Primary focus is expected to be percutaneous aortic and mitral heart valves.
Mr Lluis Duocastella commented that, “the combination of established Braile high quality heart valve technology with iVascular unique know how and vertical integration, is an ideal configuration for bringing innovative solutions to the structural heart market”.
Mrs Patricia Braile also stated that “the complementary knowledge and technologies that the two companies have will generate a new concept in innovative products and processes “.

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.
Braile Biomedica is a 40-year company based in Brazil with great experience on structural heart technologies. The company has a wide range of products for Cardiac Surgery, Interventional Cardiology, Vascular and Oncology fields. Braile is recognized as the most innovative company in Brazil and has a strong market participation inside Latin America and in developing countries.

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27 Jul

ANCHOR Study was recently published in the journal “Catheterization and Cardiovascular Interventions”

The ANCHOR study evaluating 3- and 6-month optical coherence tomographic (OCT) surveillance following percutaneous coronary intervention with the cobalt chromium Angiolite sirolimus-eluting stent system was published by Dr. Rishi Puri, Quebec Heart and Lung Institute (IUCPQ), UL, Canada et al online ahead of print in Catheterization and Cardiovascular Interventions.

Using quantitative OCT analyses, the investigators explored the healing characteristics of the Angiolite device at 3 and 6 months postimplantation. The Angiolite stent was successfully implanted in 103 patients without periprocedural complications. At 3 and 6 months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 μm and 73.9 ± 54.3 μm, mean neointimal area obstruction of 5.8% ± 10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction, or cardiovascular death, with one patient undergoing ischemia-driven target lesion revascularization.

As stated by PI of the ANCHOR study Dr. Josep Rodés-Cabau, “The main purpose of ANCHOR study was to confirm Angiolite’s promising efficacy and safety results obtained in preclinical models. At 6 months, the Angiolite sirolimus-eluting stent was safe and had high rates of strut coverage, modest degrees of neointimal hyperplasia, and very low rates of strut malapposition. These data, coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL, point toward an efficacious drug-eluting stent.”

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.

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

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