Our conference posts in the past year were already clear about positive clinical developments and perspectives in the USA. To enable customer and distributor support and supply, we have now opened an office in Columbus (OH). The facility has a QM system from which we can store and ship product throughout the USA. The manager is Michael Barilla. The office address: 7239 Sawmill Rd, Dublin OHIO 43016. Michael can be reached via cell: 614-716-8570.
PICS will be focusing on the latest interventional catheter strategies for congenital and structural heart disease in children and adults. Therefore we are eager to exhibit for first time at this annual meeting in September 2018, and look forward to share our product and process know-how on moving your cathlab procedures to the MRI. .
Step by our Booth 124 to meet the team and learn more about our products!
See you in Vegas!!
CMR 2018 was again a major step forward for interventional MRI. CMR 2018 focused on the theme of “Improving Clinical Value by Technical Advances,” emphasizing the goal of both Societies to improve clinical outcomes in cardiovascular disease through innovation. This paved the way for a complete afternoon session with a line-up of speakers showing recent advances in their centers (e.g Dallas Childrens, RFH London, Helios Leipzig) and others (e.g. San Diego, NIH, Munich) pointing at the next indications to do in MRI. After SCMR 2017 in Washington also a live case of interventional MRI was broadcasted into the plenary meeting, this time from Kings College, London by Reza Rezavi. Notably, many American clinicians were happy that an FDA registered product is now available via Nano4Imaging. It was also clear from the meeting that a lot of our customers have to go through the same cumbersome pathway with hospital authorities, platform suppliers and many others. Nano4Imaging will launch a platform soon to share best practices and connect customers.
December 15th 2017
Nano4Imaging received (renewed) CE label for its existing and new guidewire (EmeryGlide TM). Within the last quarter we have now obtained both FDA 510 K and CE labels and are eager to move forwards with our clinical and business partners to move more and more cathlab procedures to the MRI suite. We would like to thank our contract manufacturer CMI (Dresden) for their endurance and persistence to get the certifications timely. Please come and see us at the CMR2018 in Barcelona (Jan 31st -Feb 3rd 2018) or at AEPC in Athens (May 10-12th 2018). In the meantime we will also set-up our sales and clinical applications in the USA. It will be an exciting clinical year for Nano4Imaging!!
With a new energy boost we are now starting to prepare our participation at CMR in Barcelona (Jan 2018). FDA has approved the special 510K for our second generation MR compatible guide wire, and we are awaiting CE approval also soon. Next year you will see us at Barcelona CMR 2018, the world symposium on Pulmonary Hypertension (Nice) and AEPC 2018 in Athens. Let’s roll.
On september 6th a paper was published by Ratnayka et al in JCMR in which CMR fluoroscopy guided right heart catheterization was shown to be feasible and safein 39 pediatric (12.7 ± 4.7 years) subjects. The group included subjects with previous metallic implants, those requiring continuous vasopressor medication infusions, and those requiring pharmacologic provocation. Children requiring multiple, serial X-Ray cardiac catheterizations may benefit most from radiation sparing. Together with our recently finished PMCF in 25 patients, this is a next step toward wholly CMR guided diagnostic (right and left heart) cardiac catheterization and future CMR guided cardiac intervention. Read the original paper
Our Eurostars application SPECTRE received a very high score in the evaluation process and we look forward to start-up the consortium with Radboud Medical Centre (Nijmegen, NL), Soteria Medical BV (Arnhem, NL), Fraunhofer MEVIS (Bremen, DE) over the next few months. The target is to further develop catheters that allow PTA applications under MRI to further support our vision and product development towards real MRI-guided interventions, such as fistula repair and iliac stenosis repair. A big applause for TTopstart who has helped us to write the grant. Radboud UMC will be able to further extend its MITEC facility and will help to further augment MRI guided procedures.
After the live case in Washington at SCMR2017, now also ISMRM which gathers more then 5000 specialists in MRI, had a live broadcast of real time cardiac MRI in a plenary session on April 25th. Among several speakers it was prof. Razavi who explained the value of interventional MRI in cardiac diagnostics and interventions. His research group at King’s College London has been the first to apply real-time MRI to congenital heart disease more than 15 years ago.
On december 21st 2015 our MR conditional guide wire received a license (number 96312) from Health Canada. We will only start our sales in Canada, after completion of the post-market clinical follow-up (PMCF) which is ongoing in Europe. This is a great news at the end of an important year for Nano4Imaging. Thanks all for your confidence and let’s move on in 2016 the widespread clinical use of MRI based procedures.