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

Monthly Archives: October 2023

Impulse Dynamics receives full-body MRI-conditional approval for OPTIMIZER Smart Mini System

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

OPTIMIZER Smart Mini whole-body MRI

Impulse Dynamics, the company for which I am the CTO, announced that FDA has approved full-body MRI-conditional labeling for the OPTIMIZER Smart Mini IPG.  According to the announcement:

“The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.”

Medtronic receives FDA approval for Aurora EV-ICD™

Posted on by Posted in Cardioversion/Defibrillation, Medtronic, Tachycardia
Aurora EV-ICD™

Image Credit: Medtronic

Medtronic announced today that it received FDA approval for its Aurora EV-ICD™ MRI SureScan™ Extravascular Implantable Cardioverter-Defibrillator and Epsila EV™ MRI SureScan™ defibrillation lead.

According to the press release:

“The Aurora EV-ICD system is the first-of-its-kind to provide the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs.”

Continue reading→

Take an unequivocal stand for basic human decency against Hamas!

Posted on by Posted in Administrative, My Portfolio

I STAND WITH ISRAEL

Dear Friends and Colleagues,

On October 7, 2023, Hamas perpetrated horrific acts of pure evil against innocent civilians in the south of Israel. Hamas continues to launch rockets against population centers with the sole purpose of causing terror, destruction, and indiscriminate death. These crimes cannot be justified under any circumstances.

Now, a week after the terrorist attack, over seven million of my brothers and sisters in Israel, and millions of Jews around the world live in anguish about the welfare of the hostages taken by Hamas, and concerned about the safety of those in our families who have mobilized to defend our existence.

I do not ask you to take a political stance in the Israeli-Palestinian conflict. In fact, I believe that the Palestinian People are victims of Iran and its puppet Hamas’ complete disregard for human life. Instead, I ask you to take an unequivocal stand for basic human decency against the senseless and barbaric acts of terrorism perpetrated by Hamas.

Silence is complicity!