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

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.

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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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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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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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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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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.

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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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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.

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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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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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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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* = (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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• 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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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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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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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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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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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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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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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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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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