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

Monthly Archives: May 2019

Medtronic’s FY19 and Q4 2019 Financial Results: CRM & HF down 4.8%, Pain Therapies 3% up

Posted on by Posted in AIMD Business, Medtronic

Medtronic Reported its Fiscal Year and Fourth Quarter 2019 Financial Results, showing a Q4 Revenue of $8.1 Billion, Flat as Reported and Grew 3.6% Organic – Q4 GAAP Diluted EPS of $0.87; Q4 Non-GAAP Diluted EPS of $1.54.  FY19 Revenue of $30.6 Billion Grew 2.0% Reported and 5.5% Organic.

However, Cardiac Rhythm & Heart Failure fourth quarter revenue of $1.554 billion decreased 4.8 percent as reported or 1.4 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by high-twenties growth of the TYRX® Absorbable Antibacterial Envelope, high-teens growth of the Reveal LINQ(TM) Insertable Cardiac Monitoring System, and mid-teens growth in AF Solutions, all on a constant currency basis. This was offset by low-double digit declines in Heart Failure, including high-thirties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.

In the Restorative Therapies Group, Pain Therapies fourth quarter revenue of $342 million increased 3.0 percent as reported or 5.4 percent on a constant currency basis. The division had high-single digit constant currency growth in Targeted Drug Delivery, and mid-single digit constant currency growth in Pain Stimulation on the continued strength of the Intellis(TM) platform.

First U.S. Commercial Implant of Impulse Dynamics’ OPTIMIZER Smart System

Posted on by Posted in Cardiac Contractility Modulation, David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, My Portfolio

Impulse Dynamics – the company for which I work – announced during HRS that a first patient received the Optimizer® Smart System for delivering CCM™ therapy since the device was approved by the U.S. Food and Drug Administration. The implant was performed on May 6, 2019 at The Ohio State University Wexner Medical Center.

The start of commercial implants in the U.S. is a major milestone for the Company.  It makes me very proud that the technology on which I have worked for over 21 years is now available to make a dramatic change to the lives of heart failure patients across the U.S.

 

My take from HRS: Leadless Pacemakers are Entering the Mainstream

Posted on by Posted in Abbott, Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, EBR Systems, Heart Failure (CHF), Medtronic, Tachycardia

Medtronic Micra™, Boston Scientific Empower™, and St Jude (Abbott) Nanostim™. Scale is approximate

I just came back from HRS 2019 in SF, and the implantable devices buzz this year was around leadless pacemakers and defibrillators.  Most importantly, they are no longer considered a technical curiosity, but rather are entering the mainstream as a serious alternative to leaded devices.

In the bradycardia field, Medtronic showed how their MICRA™- the only commercially-available leadless pacemaker at this time – is able to pace the ventricle in sequence with the atrium through the use of a 3D accelerometer that senses the atrial contraction.

Researchers using the Boston Scientific EMPOWER™ Modular Pacing System showed how it can communicate with Boston’s  EMBLEM™ S-ICD System to provide brady and ATP pacing.

On its side, Abbott is said to be working to relaunch the plagued NANOSTIM™ leadless pacemaker after early battery depletion issues caused St. Jude to issue an advisory in October 2016, followed by Abbott maintaining the worldwide halt on implantations because of problems with the device’s docking button.

More mention is also being made of EBR’s LV pacemakers as an alternative to GCV leads to deliver CRT.

EBR’s WISE wireless LV pacemaker is powered from an ultrasonic generator implanted outside the heart.

Continue reading→

FDA approves Medtronic’s New CareLink SmartSync(TM) iPad-Based Programmer

Posted on by Posted in Medtronic

Image Credit: Medtronic

Medtronic announced that has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled implanted cardiac devices.

SmartSync is Medtronic’s next-generation programmer and pacing system analyzer.  It features a simplified user interface, enhanced security and Bluetooth® capabilities to communicate with compatible cardiac devices. Continue reading→

Medtronic Receives FDA Approval for World’s First Quadripolar Active Fixation Left Heart Lead

Posted on by Posted in Cardiac Pacing, Heart Failure (CHF), Medtronic

Image Credit: Medtronic

Medtronic announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, and is designed for precise lead placement and stability. Medtronic said that the lead will be commercially available in the U.S. in summer 2019.