Abbott wins FDA approval for next-gen TactiFlex ablation catheter

The TactiFlex Ablation Catheter, Sensor Enabled [Image courtesy of Abbott]Abbott (NYSE: ABT) + today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology.

The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result is a reduction in procedure times and improved safety compared with the company’s previous-generation ablation catheters.

Abbott officials think their next-gen radiofrequency ablation system will enable more efficient and accurate arrhythmia treatments.

“For those suffering from AFib, daily life can be challenging as people often feel dizziness, chest pain and heart palpitations. AFib can lead to stroke if left untreated, making it cr…

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Pulse Biosciences enters $65M private placement for pulsed-field ablation tech

Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a stock purchase agreement to raise approximately $65 million.

Hayward, California-based Pulse Biosciences entered into the agreement with Robert Duggan, the company’s executive chair. Duggan agreed to purchase 10,022,937 shares of the company’s common stock at $6.51 per share. That marks a greater than 1% premium over the last reported sale price of Pulse common stock on April 28, 2023.

Upon the closing of the private placement, all indebtedness owed to Duggan will be canceled as consideration for the shares. That includes the principal balance of $65 million and accrued and unpaid interest of approximately $0.25 million.

Pulse Biosciences develops its novel and proprietary nanosecond pulsed field ablation (nsPFA) technology. It also develops the proprietary CellFX System for the treatment of AFib.

“Upon closing, this transaction eliminates our debt and this ca…

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Medtronic wins CE mark for Affera ablation system

The all-in-one Sphere-9 catheter for mapping and ablation. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system.

The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides real-time feedback through its mapping and navigation software.

Sphere-9 combines with the mapping and navigation system to generate sophisticated electro-anatomical maps. These allow the physician to deliver wide-area focal ablation lesions of choice between RF or PFA. The catheter features a nitinol 9mm ablation tip that may allow for fewer focal ablation lesion applications. Medtronic said it could result in lower procedure times compared to standard irrigated ablation catheters. The compa…

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Biosense Webster marks first cases with dual energy ablation tech

The Thermocool SmartTouch SF ablation catheter [Image courtesy of J&J’s Biosense Webster]Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib.

The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be the Johnson & Johnson MedTech subsidiary’s answer to the dual energy ablation tech coming out of Affera, which competitor Medtronic acquired for $1 billion last year.

Dr. Tom De Potter performed the first procedure with Thermocool SmartTouch at OLV Hospital in Aalst, Belgium. Biosense Webster said Dr. Mattias Duytschaever of AZ Sint-Jan Brugge Oostende AV performed several additional cases. The Brugge, Belgium, hospital is also taking part in the clinical trial.

“While radiofrequency ablation has decades of safety and efficacy data to support it, pulse field ablation is a novel…

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Hologic NovaSure V5 endometrial ablation device wins European, Canadian approval

The NovaSure V5 endometrial ablation device. [Image courtesy of Hologic]Hologic (Nasdaq:HOLX) announced today that Canadian and European officials approved its NovaSure V5 global endometrial ablation (GEA) device.

Marlborough, Massachusetts-based Hologic designed the device to treat a wide range of cervical and uterine anatomies. It offers treatment for abnormal uterine bleeding.

In a news release, Hologic cites 97% patient satisfaction with NovaSure. The device also demonstrated 87% avoidance of a hysterectomy at 10 years.

“Since its launch over 20 years ago, we have constantly listened to our customers’ feedback, which has driven continuous design improvements for NovaSure,” said Jan Verstreken, Hologic group president, international. “This has enabled us to develop our technology to further meet their needs and those of the women they treat, ultimately delivering better outcomes for these women.”

NovaSure V5 features an updated cervical seal with …

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Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Affera’s Sphere-9 mapping and ablation catheter [Photo courtesy of Affera]

Affera started in 2014 with a simple goal that paid off when Medtronic (NYSE:MDT) bought the company for up to $1 billion this year.

Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said.

Newton, Massachusetts–based Affera’s system diagnoses, maps and treats heart arrhythmias with ablation. It’s a process that scars heart tissue to interrupt errant signals. Affera’s system uses both radiofrequency (RF) ablation — as well as the non-thermal pulsed-field ablation tech that has been generating buzz in medtech.

Complex arrhythmias like atrial fibrillation and ventricular tachycardia can require an electrophysiologist to perform more extensive ablation. But Harlev and his team at Affera thought a larger ablation tip could ma…

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What is the future of cardiac ablation?

Boston Scientific in July 2021 exercised its option to acquire the remaining shares of PFA tech developer Farapulse. [Image courtesy of Boston Scientific]

Pulsed-field ablation (PFA) — a non-thermal method for cardiac ablation — has the potential to positively disrupt the atrial fibrillation market.

Amid the excitement around the technology, Medtronic announced in January that it would acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. Meanwhile, Boston Scientific in February closed its $1.75 billion acquisition of Baylis Medical — the creator of advanced transseptal puncture platforms to enhance safety, efficacy and efficiency when crossing the atrial septum to deliver therapies in the left side of the heart. Months before, Boston Scientific exercised its option to acquire the remaining shares of PFA tech developer Farapulse.

Come to DeviceTalks Boston — May 10-11, 2…

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