Boston Scientific stock rises on positive Farapulse results — analysts expect FDA approval, rapid adoption

Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced positive 12-month results from the trial of its Farapulse pulsed-field ablation (PFA) system.

Shares of BSX rose 5.4% at $53.50 apiece in early-morning trading today. MassDevice’s MedTech 100, — which includes stocks of the world’s largest medical device companies — rose nearly 1%.

The pivotal ADVENT trial evaluated the nonthermal treatment for ablating heart tissue in patients with AFib. It marks the first randomized clinical trial directly comparing the efficacy and safety of Farapulse against standard-of-care ablation — either radiofrequency or cryoablation — for treating paroxysmal or intermittent AFib.

Boston Scientific presented findings at the annual meeting of the European So…

Read more
  • 0

Boston Scientific ramps up Farapulse manufacturing with new site

The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]

Boston Scientific plans to increase production of its Farapulse pulsed-field ablation (PFA) system with a second pulse generator manufacturing site.

“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.

He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”

Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).

Farapulse Inc.  secured CE mark approval for the system before being acquired by Boston Sci…

Read more
  • 0

Medtronic reports positive study results for PulseSelect pulsed-field ablation system

The PulseSelect for pulsed-field ablation. [Image courtesy of MedtronicMedtronic (NYSE:MDT) today announced positive findings from a secondary analysis of the PULSED AF study for its pulsed-field ablation technology.

The analysis demonstrated positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction. This correlated to both improved quality of life and decreased healthcare utilization.

Medtronic said in a news release that 87% of paroxysmal AFib and 82% of persistent AFib patients experienced less than 10% AA burden. The company presented results as late-breaking trial science at Heart Rhythm 2023.

The Pulsed AF trial evaluates the safety and effectiveness of PFA technology for AFib ablation. PFA uses pulsed electric fields to efficiently isolate pulmonary veins to treat paroxysmal or persistent AF. Medtronic completed enrollment in November 2021. Read more about what pulsed-field ablation is he…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

Medtronic pulsed-field ablation system exceeds safety goal in study

The PulseSelect for pulsed-field ablation. [Image courtesy of MedtronicMedtronic (NYSE:MDT) announced today that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial.

PulseSelect registered an adverse event rate of 0.7%. Medtronic said that marks one of the lowest adverse event rates of any previous FDA investigational device exemption (IDE) trial for AFib ablation or any multi-center PFA study.

The Pulsed AF trial exceeded the threshold for its efficacy performance goal, too. It demonstrated further clinical success through freedom from recurrence of any symptomatic atrial arrhythmias. That totaled at least 80% for each patient cohort.

Medtronic presented findings from Pulsed AF today at the American College of Cardiology’s Annual Scientific Session Together with the World Congress of Cardiology (ACC.23/WCC). It simultaneously published results in Circulation.

The Pulsed AF trial evaluates…

Read more
  • 0

The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive monitoring, this was an exciting year for cardiac device tech.

Here are the top 10 cardiac device stories from MassDevice and its sister sites:

10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

Read more
  • 0

Applications of electrical energy in medicine: RF ablation, pulsed-field ablation and electroporation

Learn about new and promising applications of energy-based medical systems and the challenges of developing them.

An engineer develops the pulsed waveform output for a PFA system. [Photo courtesy of Minnetronix Medical]

Daniel Friedrichs, Minnetronix Medical

While modern medicine is awash in high-tech electronics from large surgical robots to tiny implanted sensors, there are several applications where electrical energy is directly applied to a patient to ablate tissue, convey drugs, or achieve other clinical effects.

Given the obvious concerns with applying electricity to humans, developing these tools safely and effectively is crucial.

This article briefly reviews these applications of electrical energy in medicine and new opportunities to refine existing technology such as radiofrequency (RF) ablation or realize radical improvements using new energy modalities such as pulsed-field ablation (PFA…

Read more
  • 0

Farapulse founder’s Field Medical partners with CardioNXT on novel pulsed-field ablation tech

Field Medical and CardioNXT announced a strategic collaboration to provide what they say is a first-of-its-kind pulsed-field ablation (PFA) therapy.

The two companies plan to provide a purpose-built PFA therapy integrated with 3D mapping and navigation.

According to a news release, both teams bring decades of experience in pioneering novel PFA and navigation technologies. Their experiences range across various medical applications.

“PFA has generated much excitement in the treatment of atrial fibrillation due to an improved safety profile and procedural workflow. However, most of the first-generation PFA technologies today are repurposed from other applications and suffer from significant limitations outside a subset of AFib procedures,” said Dr. Steven Mickelsen, CEO of Field Medical. “This collaboration brings together second-generation focal PFA and AI-based cardiac mapping—a combination set to revolutionize catheter ablation across …

Read more
  • 0

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…

Read more
  • 0

What is pulsed-field ablation? Here’s what you need to know

Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston. Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. [Image courtesy of Boston Scientific]Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated.

PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA generally involves high-voltage electric pulses from a catheter-delivered electrode or electrodes, delivered each at a tiny fraction of a second. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury resistant.

It’s hard these days to find a cardiac device company…

Read more
  • 0

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, 2022 — and hear from leaders at Boston Scientific, Medtronic an…

Read more
  • 0