Farapulse Archives - Medical Design Sourcing

Boston Scientific has more positive Farapulse pulsed-field ablation data

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]Researchers shared positive data from a large, real-world registry of patients treated with the Boston Scientific (NYSE: BSX) + Farapulse system.

Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. The company reported an overall major adverse event rate of less than 1%.

The registry included outcomes ranging across 106 hospitals, according to Boston Scientific. Data also reinforced the reproducibility of the therapy workflow and short learning curve in uncontrolled commercial use.

Boston Scientific presented its Farapulse data at the…

Field Medical raises $14M for next-gen cardiac ablation tech

The FieldForce catheter tip. [Image courtesy of Field Medical]Field Medical announced today that it closed an oversubscribed seed round with investments reaching $14 million.

Private investors led the funding for the Cardiff-by-the-Sea, California-based cardiac ablation technology developer. Multiple strategic investors also joined the round. The company earmarked the funds to support preclinical-to-clinical development activities. That includes first-in-human studies slated to begin in early 2024.

Field Medical was founded last year by Dr. Steven Mickelsen, the founder of Farapulse. Mickelsen also serves as CEO. He led his previous pulsed-field ablation (PFA) technology developer to an acquisition worth at least $460 million by Boston Scientific in 2021. Boston Scientific recently shared positive updates on that Farapulse technology, which Field Medical could eventually look to rival.

The company’s core products, the FieldForce Catheter and FieldForc…

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…

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…

Report: Medtech dollars, deals hit new highs in first half of 2021

Fueled at least in part by exceptionally strong IPO and M&A markets, hedge funds, venture capitalists, private equity firms and corporate investors are committing more time and money into privately held medical devices companies, according to a new “Healthcare Investments and Exits” report issued by Silicon Valley Bank.

The report examining the first half of 2021 outlines deals and dollars committed to all sectors within healthcare — while also tracking exiting opportunities for investors. An examination of the medical device portion of the report reveals many promising trends.

First, capital commitments are up. Looking at dollars raised, U.S. and European medical device startups raised $4.6 billion in the first half of this year, putting 2021 on pace to eclipse totals dollars raised in 2020 ($5.2 billion raised) and 2019 ($4.8 billion raised.) It’s worth noting that European startups accounted for 34% of the dollars raised by medical device companies, up f…

Boston Scientific pulls trigger on Farapulse acquisition

Boston Scientific (NYSE:BSX) announced today that it exercised its option to acquire the remaining shares of Farapulse.

Marlborough, Mass.-based Boston Scientific first announced its intent to acquire Farapulse when it signed an investment agreement with an option to acquire the pulsed-field ablation (PFA) technology developer in September 2020.

Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27%. The transaction to acquire Farapulse includes an upfront payment of approximately $295 million for the 73% stake not yet owned, plus up to $92 million upon the achievement of certain clinical and regulatory milestones and additional revenue-based payments over the next three years, according to a news release.

The company said that, preceding consideration of current equity ownership, debt and other closing adjustments, the total transaction price amounts to $450 million upfront, up to $125 mil…