A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: AIMD Business

Boston Scientific Defibrillators Receive CE Mark for 10-Year Longevity Projections

Posted on by Posted in AIMD Business, Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Power Sources, Tachycardia

 

Boston Scientific Incepta ICD with DF-4 connector

Image Credit: Boston Scientific

Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.

Projected device longevity exceeds 10 years for some models, approaches eight years for its CRT-D devices, and according to the press release is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years:

Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.

Continue reading→

St. Jude’s Q3 2012 AIMD Results: CRM Maintains Downward Trend, Neuromodulation Steady

Posted on by Posted in AIMD Business, St. Jude Medical

St. Jude announced today its third quarter 2012 results.  From the press release:

“Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $691 million for the third quarter of 2012, an 8 percent decrease compared with the third quarter of 2011. Total CRM sales for the third quarter decreased 4 percent after adjusting for the impact of foreign currency.

Of that total, ICD product sales were $412 million in the third quarter, a 7 percent decrease compared with the third quarter of 2011. On a constant currency basis, total ICD sales declined 4 percent from the prior year.

Third quarter pacemaker sales were $279 million, a 9 percent decrease compared to the third quarter of 2011. After adjusting for the impact of foreign currency, pacemaker sales decreased 4 percent.”

…

“St. Jude Medical sales of neuromodulation products were $101 million in the third quarter of 2012, down 1 percent from the comparable quarter of 2011. Revenue for the third quarter increased 2 percent after adjusting for the impact of foreign currency”

 

EnteroMedics Reports $123k Revenue from Sales of its Maestro RC IPG for Treatment of Obesity

Posted on by Posted in AIMD Business, EnteroMedics, Obesity, Vagus Nerve Stimulation

Today EnteroMedics recorded revenue for the first time since it was incorporated nearly eight years ago. The company reported revenue of about $123,000 in the first quarter of the year from the sale of its Maestro RC implantable vagus nerve stimulation system for treating obesity. Revenue was generated through sales by its distribution partner in Australia.

This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness goal.  EnteroMedics is currently conducting a pivotal trial that is expected to end in Q4 2012. EnteroMedics expects to file a premarket approval application with the FDA in the first half of 2013 if the data from the trial is positive.

 

 

St. Jude’s Reports Q1 2012 AIMD Sales Results: CRM down 4%, Neuromodulation up 12%

Posted on by Posted in AIMD Business, St. Jude Medical

St. Jude Medical today reported sales and net earnings for the first quarter ended March 31, 2012.

Total CRM sales, which include ICD and pacemaker products, were $735 million for the first quarter of 2012, a 4 percent decrease compared with the first quarter of 2011.  Of that total, ICD product sales were $450 million in the first quarter, a 3 percent decrease compared with the first quarter of 2011. First quarter pacemaker sales were $285 million, a decrease of 4 percent from the comparable quarter of 2011.

St. Jude Medical sales of neuromodulation products were $103 million in the first quarter of 2012, up 12 percent from the comparable quarter of 2011.

Boston Scientific to Acquire Cameron Health for $150M Up-Front + $150M Upon FDA Approval

Posted on by Posted in AIMD Business, Boston Scientific, Cameron Health, Cardioversion/Defibrillation, News
Cameron Health S-ICD subcutaneous defibrillator

Image Credit: Boston Scientific

Boston Scientific announced the exercise of its option to acquire Cameron Health.  Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago.

The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD System, plus up to an additional $1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval.  Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.

DF-4 Connectors for Implantable Cardioverter Defibrillators Enter Use in the US

Posted on by Posted in AIMD Business, Boston Scientific, Cardioversion/Defibrillation, Medtronic, St. Jude Medical, Tachycardia
DF-4 Connector for implantable cardioverter defibrillators

Image Credit: St. Jude Medical

The DF-4 Connector was recently introduced by a joint group of CRM companies, physicians, and regulatory agencies as a way of easing the implant of ICDs by reducing defibrillation connections from three to one and by minimizing the number of set screws.  Prior to the development of the DF-4, traditional high-voltage connector systems required up to three connections. Continue reading→

Boston Scientific’s Active Implantable Sales for 2011: CRM Down 7%, Neuromodulation Up 10%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Today Boston Scientific Corporation announced financial results for the fourth quarter and full year ended December 31, 2011.  Summarizing the AIMD data:

  • On a constant-currency basis, Q4 2011 CRM sales were $482M compared to $564M in Q4 2010, or  down 15%
  • On a constant-currency basis, 2011 CRM sales were $2,087M compared to $2,180M in Q4 2010, or  down 7%
  • On a constant-currency basis, Q4 2011 Neuromodulation sales were $91M compared to $86M in Q4 2010, or  up 6%
  • On a constant-currency basis, Q4 2011 CRM sales were $336M compared to $304M in Q4 2010, or  up 10%

Click here for the news release.

 

 

St. Jude Medical’s Active Implantable Sales for 2011: CRM Down 3%, Neuromodulation Up 8%

Posted on by Posted in AIMD Business, St. Jude Medical

St. Jude Medical today reported sales and net earnings for the fourth quarter and year ended December 31, 2011.    From the press release:

“Cardiac Rhythm Management

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were$728 million for the fourth quarter of 2011, a 4 percent decrease compared to the fourth quarter of 2010.   After adjusting for the impact of foreign currency, total CRM sales decreased 6 percent. Total CRM product sales for the full-year 2011 were $3.034 billion, essentially equal to 2010. On a currency neutral basis, total CRM sales declined 3 percent from the prior year. Continue reading→

St. Jude 4Q IPG Sales: CRM Down 4%, Neuromodulation 12% Up vs. Q4 2010

Posted on by Posted in AIMD Business, St. Jude Medical

Yesterday, Jan 9, 2011, St. Jude Medical announced preliminary revenue results for the fourth quarter ended December 31, 2011:

“Fourth quarter cardiac rhythm management sales were approximately $728 million, a 4 percent decrease compared with the fourth quarter of 2010. Fourth quarter sales of implantable cardiac defibrillators were approximately $436 million, a 5 percent decrease from the comparable quarter in 2010. Pacemaker sales during the quarter were approximately $292 million, a 4 percent decrease compared with the fourth quarter of 2010.

…

Fourth quarter sales of neuromodulation products were approximately $121 million, a 12 percent increase compared to the fourth quarter of 2010.”

Company website: www.sjm.com