Blog Tag: Ablation

Medtronic Completes Acquisition of Cardiac Mapping Company Affera

Medtronic recently announced that its acquisition of Affera, Inc. has been completed. The acquisition was previously announced to be for $925 million with a $250 million contingency, as reported by MedCity News. Medtronic had previously been a strategic investor in Affera and, prior to the acquisition, owned a 3% interest in Affera as stated in a prior press release dated January 10, 2022.

Affera develops an integrated platform to deliver therapy to cardiac arrhythmia patients. The platform is referred to as Affera Prism-1™ cardiac mapping and navigation platform, per the announcement. Additionally, Affera also develops catheters, such as the pulmonary vein isolation pulsed field ablation catheter, as previously announced on July 27, 2021.

In the latest announcement, Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business, stated:

We’re incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology; and now these new additions to our portfolio help support a leap forward in our commitment.

Founder and chief executive officer of Affera, Doron Harlev, also expressed excitement to be joining Medtronic by stating that “the acquisition enhances and accelerates our ability to treat millions of patients around the world suffering from cardiac arrhythmia with our innovative technology.”

This acquisition would be the second acquisition completed by Medtronic this year.  Earlier this year, Medtronic completed the acquisition of Intersect ENT, the developer of sinus implant technology, for $1.1 billion, as reported by MassDevice.

First Flexible Tip Ablation Catheter To Receive FDA Approval

St. Jude Medical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its FlexAbility Ablation Catheter for use by electrophysiologists to treat cardiac arrhythmia.

The new catheter provides a unique bendable irrigated catheter tip that allows the catheter to better conform to the cardiac anatomy and more effectively form lesions during operation.  According to St. Jude Medical, the FlexAbility catheter also has an improved handle and shaft that enhance maneuverability, allowing electrophysiologists to reach challenging anatomical locations with less hand fatigue.

St. Jude’s new catheter could provide benefits to an estimated 10.4 million people in the United States who suffer from some type of cardiac arrhythmia.  According to Dr. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute:

“The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today.  For the past several years we’ve been looking for a catheter that provided a gentler, more optimal approach to ablation.  The FlexAbility catheter addresses this need and provides me with another safe treatment option for my patients”

MarketWatch reports that the FDA approval of the FlexAbility catheter, which received its CE Mark in Europe last year, bolsters St. Jude Medical’s expanding ablation portfolio, which includes various patents such as U.S. Pat. No. 8,790,341, and expands the ability of physicians to treat patients battling abnormal heart rhythms.

 

 

Vascular Solutions Indicted

Vascular Solutions Indicted

The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices.  The same charges were also brought against VSI.  According to its website, Minneapolis MN-based VSI makes medical devices for diagnostic and interventional vascular procedures.

According to the United States Department of Justice, the indictment alleges that VSI and Root ran an off-label promotion scheme to market VSI’s Vari-Lase product for the ablation of perforator veins, which connect superficial veins to deep veins. According to its 510(K) summary, the FDA cleared the Vari-Lase for treatment of superficial veins.  As the Department of Justice notes, the FDA did not approve the Vari-Lase for treating perforator veins due to higher risks associated with perforator veins’ contact with deep veins. Yet, as stated by the indictment, VSI and Root continued to promote and sell Vari-Lase for treating perforator veins even after failing to obtain FDA approval.

The Department of Justice reports that VSI and Root continued off-label promotion of the Vari-Lase even after a whistleblower complained to Root in 2009 and the government told VSI about its investigation in 2011, and VSI and Root continued to deceive the FDA by using code words and misleading investigators. The Star Tribune states that Vari-Lase was eventually voluntarily pulled from the market in July 2014 when VSI agreed to pay $520,000 to resolve civil allegations related to the same alleged off-label promotion.

Following the indictment, VSI issued a press release stating that “[t]he indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation.”  The case is now pending in the U.S. District Court for the Western District of Texas.