Is flexible robotic technology for endovascular and cardiac arrhythmia interventions really a need nowadays? Each investigator really interested in learning more about innovative SME and innovative products, especially in the medical device field, through the Internet will be able to find out how many open issues have been left unresolved by healthcare policies and management.

1. Alessandro Mazzarisi
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Flexible Robotic Catheters Industry meets EU Markets
Pdf available
October 2015
All referenced information available in here were checked on 10 October 2015

2. Introduction – Why a LinkedIn contact of mine should read this survey-story? Each
investigator really interested in learning more about innovative SME and products,
especially in the medical device field, might find this story instructive. A few crucial
questions highlighted at the bottom are waiting for readers’ comments.
!
Fig. 1 A few LinkedIn innovation groups
Anyway, I would like to inform my readers that this story was carried out by genuine intellectual,
personal curiosity only.
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3. INDEX
“A handful of disregarded dreams”
1. Based on a true story
2. Surgery cannot do without technology
3. The aim of this survey
4. Cover story
5. Regulatory and Financial Facts
6. Citizen 2.0 Personal Survey
7. Elusive, confidential, concealed or secret truth
“I was resolved to enquire into the matter of flexible robotic system installations’ magic
numbers”
8. A possible workaround
9. Competitors at home
10. The firm’s dreams
11. Numbers & Motto
“Matters linked up with the health of the Italian Healthcare System”
12. An issue generated by DRG
13. Costs and reimbursements
14. What going on out of the Italian borders?
15. Question Time
“Is flexible robotic technology for endovascular and cardiac arrhythmia interventions really
a need nowadays?”
16. Conclusion
17. Acknowledgements
References
Keywords
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4. Companies
Products
Institutions
Conflict Of Interest
Appendix
Free available resources
A1. Past related articles I wrote concerning Hansen Medical, Inc.
A2. Clinical Trials Registries
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5. A handful of disregarded dreams
1. Based on a true story - As my followers already know, I am an independent lover
of technology innovation as well as interested in healthcare policies. Recently, I have
thoroughly investigated the difficulty met by the global leader of flexible robotics
catheter system to penetrate the Italian market with their innovative vascular and
cardiac arrhythmia medical devices - Hansen Medical, Inc. (the firm).
2. Surgery cannot do without technology - Sometimes robotic technology
innovation is seen by surgical staffs and healthcare organizations just like a way to
climb on the bandwagon, but it is often the firms that guide stakeholders' choices on
technology innovation.
!
Fig. 2 An example of robotically steerable sheath
Innovation technology is seen as a desire for a sophisticated toy without bothering to
assess the real impact of management of healthcare processes, outcomes, actual costs,
etc.
3. The aim of this survey - As far as disregarded dreams are concerned, the firm
being discussed has promised to build a new generation of innovative medical
devices that would empower and protect physicians while providing enhanced care
for patients. So, I have personally taken to investigating a few matters concerning the
firm’s Go-To-Market-Strategy. In this brief report, I would like to share my recent
experience in approaching this kind of innovative technology.
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6. 4. Cover story - This firm, - a Small Medium Enterprise (about 200 employees),
based in Mountain View California - bumped into market sale issues when it tried to
deal with European Healthcare Systems.
I came to know this company when it was at its highest in the press, immediately
after it launched its last generation of Sensei®X2 Robotic System for cardiac
arrhythmia and its Magellan™ Robotic System for manipulation of vascular catheters
able to lead-up to 10-French robotic guides, performing fast and predictable
procedures.
5. Regulatory and Financial Facts - European Economic Area (“EEA”) regulations
require CE Certificates of Conformity for medical device products - Hansen Medical
Inc., received a CE Certificate of Conformity for Sensei System in September 2006,
Artisan catheters in May 2007, Magellan System in July 2011, Magellan Robotic
Catheter and related accessories designed for use with the Magellan System in
October 2011, their Artisan Extend catheters in February 2013, Magellan 6Fr Robotic
Catheter in October 2014 and their Magellan 10Fr Robotic Catheter in April 2015.
!
Fig. 3 Regulatory and International Agreements
According to the financial markets trend (NASDAQ:HNSN), this technology reached
its highest peak gripping the European market by the end of 2014 when Hansen
Medical European headquarter based in London, entrusted the management of their
flexible robotics systems and consumables to local agencies (for Italy and
Switzerland - AB Medica S.p.A.).
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7. 6. Citizen 2.0 Personal Survey - Enhanced by Internet, I gathered all available
evidence based on videos, scientific papers, clinical trials together with producer and
sponsored-clinical advertisement websites concerning: enhanced clinical physicians
capabilities, hospital economic solutions, and advanced robotic therapies for patients.
Eventually I reached my honest opinion of independent observer about the
effectiveness and usability of these technologies.
!
Fig. 4 Internet resources give anyone the chance of becoming an aware citizen [PAPM]
7. Elusive, confidential, concealed or secret truth - I am a technician, not a
physician. So, according to clear and incontrovertible scientific literature, I got
curious to learn from my colleagues - physicians involved in cardiology and
electrophysiology departments - what they already knew about this innovative
technology. As many other innovations, even Flexible Robotics Technology seems a
promising opportunity offered to European as well as Italian professionals who often
find it hard to jump on the bandwagon. I was interested in professionals’ mood and
feelings.
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8. I was resolved to enquire into the matter of flexible
robotic system installations’ magic numbers
At first, I focused my attention on the 2014 exclusive distribution agreement between
Hansen Medical, Inc. and AB Medica S.p.A. for Italy and recently for Switzerland. I
believe this partnership represents a weakness of the USA industry to deal with
European Healthcare System. Even so, a broad analysis of pros and cons can hardly
account for the limited adoption of flexible robotic technologies in both vascular and
electrophysiology segment of the Italian healthcare system.
Local resellers are used to taking care of sales promotion, gathering-patient
campaigns, market monitoring, technological and clinical support in partnership with
the firm.
Anyway, in my opinion, they might do better. They should extend the available
training facilities to accommodate physicians and their staff in different Italian
geographical locations, especially in those areas devoted to robotic academia.
Magellan™ Robotic System and Sensei®X2 require specific training. As the
opportunities to experience training systems are just available at scientific
congresses, in my opinion, due to the difficulty of joining public events, just relying
on demo events at meeting certainly doesn’t boost Robotic Systems market
acceptance nor penetration.
Moreover, the limited number of procedures prevents Italian’s staff to participate in
clinical trials already taking place in Spain, Germany, France, Denmark and the UK
[CT1, CT2].
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9. 8. A possible workaround - In Pisa, the city where I live, there are three universities
focused on innovation, two world-renowned robotic schools, and a university hospital
that plays a role in test-bed for innovative products developed by universities, start-
ups and SME. In my opinion, Pisa is the right place where to build a new robotic
school. Once they have reached an agreement with the local scientific community,
Hansen Medical, Inc. together with AB Medica S.p.A. could then share innovative
devices and simulators. Each new school will let new students and professionals
know these technologies thoroughly.
9. Competitors at home - Pushing Magellan™ Robotic System and Sensei®X2, the
Company is aware of playing with their own competitors having many overlapping
clinical scenarios. The mini-invasive surgery is driven by Da Vinci solution
[Intuitive Surgical, Inc.], that shares many patents, FDA authorizations and CE with
Magellan™ Robotic System and Sensei®X2. Da Vinci represents the most common
mini-invasive technology worldwide used. Yet the same is not true for Hansen
Medical, Inc.'s robotic solution.
10. The firm’s dreams - This firm believe the next-generation robotic catheter
systems overcomes the limitations of manual technique by facilitating accurate
positioning, manipulation, and stable control of catheter and catheter-based
technologies during electrophysiology (EP) procedures. Unfortunately they dreams
clash with the effectiveness of their numbers.
11. Numbers & Motto - I know we are all flooded by numbers at any times, but if
we give a sneak peek at the tables below, we can understand much more about the
mood and operating highlights of this Company.
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10. * = (Second quarter only)
"The Company is committed to further expanding the deployment and utility of its
robotic platforms, growing its installed base, maintaining its leadership position in
R&D, monitoring its expenses, and improving its cash inflows to progress towards
profitability" reads Hansen Medical's challenge and recurrent motto.
Anyway, what is reported above requires some clarifications so that I can avoid the
nuisance of being sued, and you won’t lose your storyteller [MarketWatch Press
Release].
• I gathered these unofficial data through recent public Company’s news just by
myself, so I might have reported some misleading details.
• In order to stay updated on the Company I subscribed their newsletter that informs
readers about innovative procedures delivered in the USA and abroad areas.
Procedures – first six months 2014 2015
Magellan Robots 180 250
Sensei Robots 1720 1760
Sold first six months 2014 2015
Vascular catheters 190 357
Catheters 928* 1729
Period Sold Systems
Second Q 2014 5
First Q 2015 5
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11. • But the most important information you can obtain from my brief report/survey is
about the power of the Company’s global market numbers, so that everyone can
judge the firm’s pep, vibrancy and vitality [MarketBeat].
Matters linked up with the health of the Italian
Healthcare System
12. An issue generated by DRG - The main fears of Hansen Medical, Inc. are about
the feasibility to obtain insurance coverage together with reimbursement from the
USA Healthcare and EU Systems. The challenge of hospitals’ administrators to fight
against unfit and obsolete DRG codes, in my opinion, is one of the main reasons that
limits the penetration of this technology. For example, although the majority of
procedures performed using Sensei®X2 technology fall under DRG 251, there is no
favourable evidence for hospitals to use these extra devices to improve: outcome,
reducing operational time, reducing the exposure for both physician and patient,
improving results and extending the patient's chances to be cured thanks to the inner-
precision technique that is offered by flexible robotic catheters.
13. Costs and reimbursements - In past times, healthcare stakeholders promoted
studies to highlight how DRG system did not match new incoming technologies due
to its elderly conception. I do not know what a DRG-revision might require, but
unfortunately the acceptance of these technologies by hospitals and physicians is
strongly dependent on costs and reimbursements.
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12. 14. What’s going on out of Italian borders? – Here a few recent news from
market’s heartbeat [News]:
• October 2015 - The first support for sharing vascular robotic arm has been sold to
allow multiple catheterization rooms to use robotic technology profitably.
• October 2015 - New York has its first flexible robotic system.
• September 2015 – In the UK the first robotic assisted Prostatic Artery
Embolization (PAE) was delivered.
• May 2015 - Melbourne, Australia, World's First Clinical Procedure With New
Magellan(TM) 10Fr Robotic Catheter.
15. Question Time - As an external and independent observer, I ended my research
in front of a wall of matters beyond my grasp and personal intervention.
So once again, I am here to ask every endovascular surgery expert and
electrophysiology expert his or her opinions on the central question here being
debated:
“Is flexible robotic technology for endovascular and cardiac
arrhythmia interventions really a need nowadays?”
Moreover, I would like to ask my readers and myself:
1. Are physicians so dependent on economic bonds to the point of ignoring safety
and outcome improvements available with new technologies?
2. Are difficulties to address elective pathologies from peripheral centres to qualified
surgical hubs, in the name of Italian parochialism, still concealing professional
lobbies’ interests?
3. The amount of flexible robotic installations sold per year and the number of
procedures done per year, suggest that physicians and hospitals do not believe that
Magellan™ Robotic System and Sensei®X2, and Artisan catheters are a viable
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13. alternative to existing mapping technologies used in vascular, atrial fibrillation
and other cardiac ablation procedures. How does it depend on naive technology or
adverse economic advantages?
16. Conclusion - Each investigator really interested in learning more about
innovative SME and innovative products, especially in the medical device field,
through the Internet will be able to find out how many open issues have been left
unresolved by healthcare policies and management.
Hoping to help those readers interested in inquiring by themselves, I reported here a
few examples of literature concerning specific subjects handled by Hansen Medical,
Inc. [a full list of related articles are available on Hansen Medical, Inc.'s web site –
Vascular, Cardiac Arrhythmia]
• Fields where flexible robotic catheter systems are relevant for vascular and
cardiac arrhythmia [01, 02, 04].
• The technique lets operators work remotely, far from patients’ beds reducing their
radiation exposure [03].
• Recent studies show an increased daily cath lab capacity through the
implementation of a robotics programme in those centres that have managed
gathering elective patients successfully [KSC].
17. Acknowledgements – I would like to thank you, brave investigators who has
read how this story has been built.
____________________
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14. Alessandro Mazzarisi - I am a visionary technician with over thirty years
of experience working with teams whose focus is on integrating
technology into our healthcare systems. Passionate about innovation, as
well as on improving healthcare and education, I have worked in
different roles with public and private companies, government entities and
universities in Europe. I have taken part in the growth of Italian biomedical
engineering, ICT and EHR infrastructures. Currently my focus is on developing
effective software solutions for innovative EU-projects at the Italian National Council
of Research. I have recently resolved to enter university.
References
[01] Vascular References
[02] Extensive Real World Experience References
[03] Reduce Fluoroscopy References
[04] Enhanced Benefit of Contact Force Sensing Catheters
[KSC] Kaiser-CVB-May2011-Arlington.pdf
[PAPM] Patient Activation for a Participatory Medicine - Internet's resources give
anyone the chance to become an aware citizen by better understanding the
opportunities offered by technology, financial markets and government policies.
Keywords: SME, Go-To-Market, DRG, Flexible Robotic Catheters - Atrial
Fibrillation, Cardiac Arrhythmia, Vascular, Endovascular
Companies: Hansen Medical Inc., Intuitive Surgical Inc., AB Medica S.p.A.
Products: Magellan™ Robotic System, Sensei®X2 Robotic System, Da Vinci
Institutions: Università di Pisa, Scuola Superiore Sant’Anna, Scuola Normale
Superiore.
Conflict of interest: none - Neither Hansen Medical Inc. nor Italian distributor of
their medical devices AB Medica S.p.A. have sponsored this story, even though at the
moment I am a Hansen Medical Inc. citizen 2.0 stockholder, according to my
personal manifest .
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15. Appendix
Free available resources
1. Past related articles I wrote concerning Hansen Medical, Inc.
2. Clinical Trials Registries
A1. Past related articles I wrote concerning Hansen Medical, Inc.
a) Sneak a peek on weakened US Medical Device Market
b) Healthcare policy and delay of TTIP are slowing innovative SMEs
c) Citizens 2.0 will disrupt financial marketplaces
A2. Clinical Trials Registries
From the website ClinicalTrials.gov a service of the U.S. National Institutes of Health
two examples of worldwide clinical trials registry.
1. Gather both retrospective and prospective case data on the use of the
commercially available Magellan Robotic System and Magellan Robotic
Catheters in accordance with the approved intended use. France, Germany;
[2013-2018] https://clinicaltrials.gov/ct2/show/study/NCT01984437
2. Assess the safety and performance of the Hansen Medical Sensei Robotic
System and Artisan Catheter when used to robotically manipulate RF ablation
catheters for the treatment of paroxysmal atrial fibrillation. Spain, United
Kingdom, Demark; [2013-2016]
https://clinicaltrials.gov/ct2/show/NCT01122173?term=sensei&rank=1
From the website Trialdetails.com using quoted search keyword “Hansen Medical
Robotic” professionals can stay up-to-date.
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16. Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
Status: Recruiting
Study Phase: N/A
Start Date: July 2013 | Completion Date: November 2016
Condition(s): Paroxysmal Atrial Fibrillation
Officials: Joseph Gallinghouse, M.D., Andrea Natale, M.D., Brenda Cayme, RN.,
BSN
Trial Contacts: Tina Schaffner, Laura Peterson, Meryna Manandhar, Claudia Irmiere,
RN, Erickia Channell, Tara Craig, RN, Deb Cardinal, Morgan Yrshus, Mary Jane
Strickland, Olga Vojvodicova, Lene Simonsen, Mercedes Ortiz, Ellie Corps
The purpose of this study is to assess the safety and performance of the Hansen
Medical Sensei Robotic System and Artisan Catheter when used to robotically
manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation
(irregular heartbeats originating in the upper chambers of the heart). Read More
Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation
Status: Terminated
Study Phase: Phase 4
Start Date: April 2008 | Completion Date: September 2013
Condition(s): Atrial Fibrillation
Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of
life of large numbers of people in the UK and around the world. Catheter ablation is a
minimally invasive treatment that has been developed to help eliminate AF. It is a
complex procedure to perform so only a few hospitals are able to offer this treatment
in the UK. A new technology allows the operator to guide their catheters (thin wires)
in the patient by using a robotically steered sheath. This allows accurate and precise
navigation that may improve the accuracy and integrity of ablation. We aim to prove
whether this technology can make AF ablation easier and more effective. Substudy:
Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and
urine samples will be taken pre- and 3 months post ablation to see if platelet
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17. reactivity and activation are affected by AF compared to established normal ranges,
and whether curative ablation impacts on this. Read More
Embolization Procedures in the Peripheral Vasculature Using the Magellan™
Robotic System
Status: Recruiting
Study Phase: N/A
Start Date: April 2014 | Completion Date: August 2016
Condition(s): Peripheral Vascular Disease
Officials: Brenda Cayme, RN, BSN
The purpose of this prospective study is to gather procedural use and safety data on
the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6
Fr and Vascular Accessories 6 Fr. This study will focus on, but not be limited to,
endovascular embolization procedures in the peripheral vascular, for example,
embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE),
prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).
The data will be analyzed for medical education, societal presentation and/or
publication by the investigator. Read More
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18. Registry of the Magellan Robotic System
Status: Recruiting
Study Phase: N/A
Start Date: November 2013 | Completion Date: November 2018
Condition(s): Peripheral Vascular Disease
Officials: Jean Bismuth, MD, Brenda Cayme, RN, BSN
Trial Contacts: Karen Manrique, Marie Ardid, Marien Bryson, Trisha Brunner,
Rachel Kronmangross, Camille Schmidt, Merle Siems
The purpose of the registry is to gather both retrospective and prospective case data
on the use of the commercially available Magellan Robotic System and Magellan
Robotic Catheters in accordance with the approved intended use. For prospective
cases, follow-up patient data will be collected at 14 days (± 5 days) post procedure to
assess treatment success, primary patency of intended targeted vessel region, and
adverse events. The data will be analyzed for medical education, societal
presentation, and/or publication by the investigators. Over the next 2+ years,
physicians who meet the selection criteria will be invited to participate in the registry.
Read More
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular
Tachycardia
Status: Recruiting
Study Phase: N/A
Start Date: October 2011 | Completion Date: December 2017
Condition(s): Ventricular Tachycardia
Officials: Prapa Dr Kanagaratnam
Investigators: Dr Prapa Kanagaratnam, Prof. Richard Schilling, Dr Kim Rajappan
Trial Contacts: Vishal Luther, MBBS MRCP, Prof. Richard Schilling, Dr Kim
Rajappan
Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a
heart attack and can cause sudden death. Patients at risk of this rhythm disturbance
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19. usually receive an implantable cardioverter defibrillator (ICD) that can prevent death
by returning the heart's rhythm back to normal by electrically stimulating the heart
but in doing so gives the patient painful and debilitating shocks. The first ICD shock
after implantation appears to be a powerful predictor of subsequent shock therapy as
well as being a predictor of of increased mortality in patients with primary prevention
ICDs. In patients who receive repeated shocks VT ablation is performed to 'burn' the
abnormal area of the heart that causes the problem. However, it is often only
performed as a last resort as it is technically challenging. We believe that performing
VT ablation using the robotic system early after the first episode of VT after ICD
implantation, may reduce the number of painful shocks received by the patient and
possibly increase life expectancy and quality of life. 200 patients from 5 european
countries will be recruited in a prospective, open, randomised trial. Eligible,
consenting patients who have experienced their first episode of VT since ICD
implantation, will be randomised in a 1:1 manner into treatment arms of either VT
ablation or standard 'conventional' therapy and followed-up every 4 months over two
years to assess the number of subsequent ICD shocks, hospitalisation, mortality and
quality of life. Read More
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