Mechanical Circulatory Assist Market

An Assembly of Analyst Reports, White Papers and News

White Papers

A new phenomenon: Elastic innovation, reconfigure how wealth is created.3-12-2012 A New Phenomenon

The mantra of the past decade has been innovation. A widespread expectation, or hope, has been that innovation will help companies to align with the new economic order in a confusing world.


Capturing the Chaos of Innovation – A Collection of ArticlesSynCardia Heart

Capturing the Chaos of Innovation to create order so that time can be compressed and outcomes accelerated


The Consolidation of the Mechanical Circulatory Assist Spacearrows

A report on the history and current status of the Mechanical Circulatory Assist market



Analysis Reports and News

Cardiovascular Devices: Heartware’s Positive Panel Vote: What It Means for HTWR and THOR

After the close on Wednesday, an FDA advisory panel voted that the benefits of Heartware’s HVAD as a bridge-to-transplant device outweighed its risks, clearing the way for a US approval and launch later this year. HTWR Positive Panel Vote – What It Means

HeartWare jumps $116 MM in market cap subsequent to FDA Advisory Panel nod of approval on the HVADHeartWare Jumps 116MM

The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System (HVAD) as a bridge to heart transplantation for patients with end-stage heart failure.

The CE and FDA approved SynCardia Total Artificial Heart Receives FDA Humanitarian Use Device Designation for Destination TherapyThe CE and FDA Approved SynCardia TAHT 1

SynCardia Systems has received a Humanitarian Use Device (HUD) designation for its total artificial heart to be used for destination therapy.

SynCardia Systems – For Artificial Heart, Smaller Is BetterArtificial Heart - Smaller Is Better

A smaller artificial heart is better for smaller people. Along with the Freedom Driver and a large and small heart SynCardia my grow to $300MM in annual Sales.

The SynCardia Total Artificial Heart received HUD Designation for Destination Therapy from the FDAzorzetto_bike

Approval of HDE Will Allow UP To 4,000 U.S. Patients Not Eligible For Transplant To Receive The Total Artificial Heart On A Permanent Basis

SynCardia Total Artificial Heart and its Freedom Driver: a top invention of the 21st Centuryfeatured image

For this National Science Day, what are the most talked about developments of the 21st century? These developments have redefined the way we lead our lives today.

The NO Pulse Artificial Heart of the FuturePopular science cover

MicroMed HA5, is now approved by the FDA and has also been part of the Texas Heart Institute Study of the No Pulse Artificial Heart.

The Artificial Heart, not just a pump – Scientific American December 2007The Artificial Heart Logo

The goal of building a safe artificial heart has frustrated bioengineers for more than four decades. At last, an end is in sight as SynCardia provides patients Freedom to live a normal life The Artificial Heart – SynCardia Freedom and Scientific American reports the past.

Acquisitions in store for Boston Scientific | Wall Street Beatwall_street_beat

Boston Scientific plans to use the bulk of the $1 billion of the free cash flow it expects to generate this year on acquisitions, according to CFO Jeff Capello

Thrombosis reports chase Thoratec Investors to the sidelinesimage001

Canaccord Genuity believes that THOR growth will slow in 2012-2015E on reports of increased pump Thrombosis and HeartWare’s pending approval of the HVAD.

The Awards mount for SynCardia and patients go homeSynCardia Heart

SynCardia has been nominated for one of the most prestigious awards in the European Medical Device industry.

SynCardia Nearly Doubles Sales for Second Straight Year in 2011heart_device

SynCardia Systems, manufacturer of the only total artificial heart approved by regulatory agencies in the U.S., Canada and Europe, announces that sales have nearly doubled for the second straight year. Sales in 2010 doubled over 2009. SynCardia ended 2011 as another double. 2012 is projected as a break-out year. 2012 1-04 – SynCardia Nearly Doubles Sales [...]

Thoratec May Entice J&J, Medtronic, Abbott, Oracle Sayshandshake

Thoratec Corp. may attract bids from Johnson & Johnson, Medtronic, or Abbott Laboratories if the company seeks a buyer, reports Oracle Investment Management.

Artificial Heart at Micromedmicromed_heart2

Texas Heart Institute and MicroMed Cardiovascular, Inc. of Houston Texas announced today The announcement was made during the opening of the 6th Annual European Mechanical Circulatory Support Summit in Paris. A new record has been established for an animal supported by an Electronic, Continuous Flow, Total Artificial Heart. A calf was successfully supported for 91 [...]

One of America’s Most Promising Companies according to Forbes Magazine – SynCardiaforbes_promising

Forbes selected SynCardia as one of “America’s Most Promising Companies.” The list features 100 privately held up-and-comers with compelling business models, strong management teams, notable customers, strategic partners and precious investment capital. SynCardia was the only Arizona Company selected and was ranked at #77.

SynCardia honored as one of six finalists of the 2011 World Technology Award for Health and Medicine at the 2011 World Technology Summit.wtn

SynCardia Systems, Inc., manufacturer of worlds only CE and FDA approved Artificial Heart, has been inducted into the World Technology Network (WTN) as a new Corporate Member. Membership can only occur through the annual Awards process, in which individuals and companies are selected via the judgment of the current WTN Fellows. SynCardia was selected as [...]

Bioscience Company of the Year – SynCardiaarizona

SynCardia was named the Arizona Bioscience Company of the Year by the Arizona Bioscience Association (AZBio).  The award recognizes the for-profit bioscience company whose Arizona based operations did the most to transform the world during the last 12 months. “SynCardia makes it possible for patients awaiting donor hearts to not only survive the wait but [...]

Interest in VAD Market Remains Strong; U.S. Market Development is Keyman_suit

Analysts Piper Jaffray report: “We are incrementally more positive on neutral-rated Thoratec after attending the HFSA convention in Boston. We continue to view the under-penetration of VADs in the U.S. as an opportunity for Thoratec.” 2011 09-23 Interest in VAD market remains strong  

Australian Award for Excellence in Medical Technology won by SynCardiamtaa

The Medical Technology Association of Australia awarded SynCardia the coveted Kerrin Renni Award of Excellence in Medical Technology. The award recognizes the extraordinary contribution of the Total Artificial Heart in improving health outcomes of Australian patients suffering from stage 4 heart failure. St. Vincent’s Hospital of Sydney made the headlines when it performed the Southern [...]

Space shuttle technology that fell to Earth: The Artificial Heartspace_technology

The Space Shuttle Atlantis lifted off at 11:20 a.m. Eastern time July 8, marking the beginning of the end for the shuttle program. NASA didn’t invent the MicroMed Artificial Heart, but the technology used in space shuttle fuel pumps led to the development of a miniaturized ventricular assist pump by NASA and renowned heart surgeon [...]

Medical Device and Diagnostic Magazine (MD+DI) names SynCardia as a top 50 company to watchmddi

The Medical Device and Diagnostic Magazine selected SynCardia because the “Total Artificial Heart” is the only device of its kind with regulatory approval in the Unites States, Canada and Europe.  The Artificial Heart is meant for people dying from end stage biventricular failure. There is no waiting list for the Artificial Heart like there is [...]

Management Meeting Takeaways Reaffirm Canaccord’s Buy Thesisyellow_arrow

Canaccord reports that mudslinging in the LVAD industry has distracted investors from focusing on the robust growth potential that exists in the LVAD market.

Solid HVAD Data at ISHLThvad

Canaccord Genuity rates HeartWare a “buy.” Important new data shows six-month survival remains outstanding.

SynCardia #20 on the FastCompany 50 Most Innovative Companies to for 2011fastcompany

The Artificial Heart and its lightweight portable driver landed SynCardia as Number 20 on a list of distinguished companies. Among the companies on the list are: Google, Apple, Nike, Twitter, Facebook, E-Bay, ESPN, Amazon, Trader Joe’s and Cisco. According to FastCompany: “The world of the future will be ruled by the kind of companies on [...]

Strong Q4; Gearing Up for U.S. Launch and Continued EU Ramphvad

Canaccord reiterates “buy” rating and remains bullish on the long-term growth prospects for HeartWare in a global LVAD market. 2011 02-25 HTWR – Strong Q4 – Buy – JMills

2011 Street Expectations Moderating

UBS Investment Research reports: “Given compelling clinical benefit, we remain optimistic on long-term LVAD opportunity but admit uncertainty as to mid-term trajectory.” 2010 10-29 THOR Street expectations moderating

FQ1:2011 Results; Impella Utilization Growth Continuesheart

Wedbush predicts continued organic growth will drive Abiomed to profitability. Report ranks Abiomed among a small group of cardiac device companies demonstrating consistent and sustainable growth. 2010 08-04 Abiomed continues to penetrate the market – _FQ1 Earnings

Jason Mills: No. 5 for Bullish Calls

Zacks Investment Research ranks Jason Mills, Canaccord’s Managing Director of Equity Research, in first place when it comes to evaluating medical device industry stocks. 2010 06-14 THOR and HTWR buys Jason Mills

M&A Looms on Med Tech Horizonpuzzle_pieces

Canaccord Genuity analyst Jason Mills identifies five companies that, in his view, are most likely to be targeted for mergers and acquisitions over the next 12 months. 2010 06-14 M&A Looms on Med Tech Horizon

Levacor Designed for Improved Blood Handling but Awaiting Clinical Data

Two players, Thoratec and HeartWare, are widely expected to dominate the LVAD market in the near future. 2010 02-02 WHRT Initiation – Wedbush

FDA Approves HeartMate II for DT; Expect Near-Term Volatilityfda_approved

Thoratec’s lead device, the HeartMate II, receives FDA approval for Destination Therapy. 2010 01-21 THOR FDA HMII Approval

Thoratec Loan Facility Updatemoney

HeartWare repays $20 million loan from Thoratec in full. 2010 01-04 HeartWare $20MM Loan from THOR

Giving a Heart a Hand: A New Mechanical Pump Offers Heart-Failure Patients an Alternative to a Transplanthearthand

The Wall Street Journal reports on the HeartMate II and the benefits it offers heart-failure patients. 2009 12-15 WSJ Alternative to Transplant – LVAD Destination

Consolidation Through Merger or Acquisition—A Matter of Timefish

In the past 12 months, some VAD companies have merged and others have gone out of business. The real question is, “Which medical device company will strike first and seize the opportunity?” 2009 12-04 Consolidation through Merger or Acquisition

Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Devicenejournal

The New England Journal of Medicine report concludes that treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improves the probability of survival free from stroke and device failure. 2009 12-03 Advanced Heart Failure Treated with Continuous Flow Left Ventricular Assist Device

HeartWare Lines Up Big Bucks to Fund Future Operationsrollmoney

HeartWare International Inc. amasses cash — including a $20 million assist from one-time merger partner Thoratec Corp. — to help fund development and sales of the company’s miniaturized implantable heart pumps. 2009 08-11 Consolidation Pumps UP and HTWR piles up CASH

HeartMate II Destination Therapy FDA Submission Ahead of Time Linepen_paper

JMP Securities maintains its Market Outperform rating and $39 price target on Thoratec following the company’s announcement that it had filed an FDA approval request for the Destination Therapy indication for its HeartMate II ventricular assist device about six weeks ahead of schedule. 2009 04-21 THOR outperforms JMP

Continued Confidence on HeartMate II Following Field Check Updatedoctors

JMP Securities reports destination therapy referrals are off to a stronger than expected start, leading to predictions that the market should be the next growth engine for Thoratec. 2009 03-19 THOR JMP continued confidence. pdf

Study Reveals 37 percent of LVAD Patients Later Need RVADheartdevice

Medical Device Daily reports that predicting post LVAD-RV failure requiring mechanical support is anything but easy. 2009 03-04 – 37% of LVAD patients experience right heart failure – TAH

Thoratec Announces HeartWare Acquisition6101

Thoratec Corp. agrees to buy HeartWare International Inc. of Australia for $282 million in cash and stock. 2009 02-17 Nash on Thoratec

Thoratec to Merge with HeartWare for $282 million

HeartWare International confirms that it will merge with Thoratec Corporation . In addition to the $282 million purchase price, Thoratec will provide a loan of up to $28 million to fund ongoing operations until the second half of 2009. 2009 02-16 HeartWare Merger Announcement -THOR

Ventracor Files Request for Suspensionventracor

Ventracor Ltd. requests that the Australian Securities Exchange suspend trading of the company’s securities. 2009 02-10 VCR suspends trading on ASX

Heart-pump maker seeks life supportventracor_logo

Less than a year after its chief executive was given a $265,000 bonus, heart-pump maker Ventracor is on life support after a last-ditch capital-raising attempt failed. 2008 12-12 Ventracor Fall from Grace

Successful Completion of International Clinical Trialclimbingchart

HeartWare International announces the completion of patient enrollment in its international clinical trial of the HeartWare Ventricular Assist System. 2008 12-05 Bob Hopkins, Analyst and HW interview

Initiating Coverage of Thoratec: Cardiac Assist Begins its Breakout

Analysts at Stifel Nicolaus report: “We believe the cardiac assist market is in the early stages of a long-term market breakout and could develop into one f the next multi-billion markets within medical devices over the next several years.” 2008 11-03 Thoratec Stifel Nicolaus initiates coverage

Technology and Regulatory Breakthroughs Bode Well for Makers of Cardiac Assist Devices

The heart-assist device market could reach between $8 billion and $10 billion worldwide within the next few years. 2008 10-01 Mechanical Heart Assist Market Analysis

ABMD: 100 Centers Penetrated, Encouraging on Both Commercial and Trial Enrollment Fronts

Abiomed announces that its Impella 2.5 VAD is now commercially available in 100 hospitals in the United States. 2008 09-30 Abiomed Impella LCM BUY

MicroMed Cardiovascular Purchased and Taken Private by David Mackstaller and Rodger Ford and Some SynCardia InvestorsDavid and Rodger

MicroMed Cardiovascular, Inc. (OTCBB: MMCO), (“MicroMed”) completed all necessary steps by September 9 of 2008 and became private. The final step in the process was a reverse split of its common stock and a repurchase of the fractional shares from the MicroMed shareholders holding smaller positions. At the time of the reverse split, E-Wilson LLC [...]

Paradigm-Changing Q2 Results

Thoratec reports $10.9 million net earnings in the second quarter of 2008. 2008 08-01 Thoratec – Paradigm Changing Q2 Results CanaccordAdams

HeartWare Company Update: Hitting Milestones

International trial enrollment is complete, a significant milestone for HeartWare. The company will be in a position to file with the European regulatory agency during the fourth quarter of 2007. 2007 11-01 HTWR hitting Mikestones – GEcapital analysts review HeartWare

LVAD Market Size Estimates

The actual market and the rate of growth for LVADs for destination therapy during clinical trials is an unreliable predictor of market growth following approval of the first suitable device for destination therapy. 2007 05-09 Ventracor LVAD Market Size Estimates

HeartWare Moves Towards NASDAQ Listing

HeartWare files its registration statement with the U.S. Securities and Exchange Commission. 2007 05-01 HeartWare moves toward NASDAQ

Im Wartezimmer der kranken Herzen (In the Waiting Room of Broken Hearts)

German newsmagazine Bild features artificial-heart recipients. 2007 02-23 BiVad vs TAH

Thoratec: Competition Falling Behindfallingbehind

Lehman Brothers reports: “THOR has been our best small-cap idea over the last 8 months and continues to be one of our top picks.” 2005 12-01 THOR Competition Lehman- Bob Hopkins

Cardiac Replacement with a Total Artificial Heart as a Bridge to Transplantationhearthookedup

The New England Journal of Medicine reports that implantation of the total artificial heart improves the rate of survival to cardiac transplantation and survival after transplantation. 2004 08-26 New England Article on the TAH

Left Ventricular Assist Devices as Permanent Heart Failure Therapy

The Annals of Surgery concludes the cost of long-term LVAD implantation is commensurate with other life-saving organ transplantation procedures, and will likely continue to decrease in the future. 2003 10-01 Left Ventricular Assist Devices as Permanent Heart Failure Therapy- The Price of Progress

Thoratec, Thermo Cardiosystems Plan Mergerclimb_graph

Thoratec Laboratories Corp. and Thermo Cardiosystems Inc. announce their merger and the creation of Thoratec Corp. 2000 11-15 THOR and Cardiosystems (Heart Mate 2) plan merger