ablation Archives - Medical Design Sourcing

FDA grants breakthrough nod for water vapor ablation therapy from Francis Medical

Francis Medical’s cancer ablation device delivers water vapor that cools and kills cancer cells. [Image courtesy of Francis Medical]Francis Medical announced that the FDA granted breakthrough device designation for its Vanquish water vapor ablation therapy.

The Minneapolis-based company designed its proprietary, minimally invasive Vanquish therapy to treat prostate, kidney and bladder cancer.

Vanquish water vapor technology applies the thermal energy stored in drops of water to deliver targeted treatments to cancerous tissue. It takes place through a simple transurethral procedure. Francis Medical designed Vanquish to ablate cancer cells while protecting the surrounding structures. This lessens the likelihood of life-altering side effects that can come with other prostate cancer treatments.

Francis Medical remains in the process of initiating its VAPOR 2 pivotal study in support of submission for FDA clearance. The trial aims to treat 235 patients wit…

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…

Relievant Medsystems reports positive data for nerve ablation procedure

The Intracept procedure. [Image from Relievant Medsystems]Relievant Medsystems announced today that three-year data from two clinical trials further validate its Intracept procedure.

Intracept, a minimally invasive, FDA-cleared, same-day, outpatient procedure, treats chronic vertebrogenic low back pain. It uses targeted radiofrequency energy to ablate the basivertebral nerve (BVN), stopping it from transmitting pain signals to the brain. The procedure takes approximately one hour to perform.

Minneapolis-based Relievant’s three-year pooled results validated the safety, effectiveness and long-term durability of Intracept. The company published the study results in Interventional Pain Medicine. Those results proved consistent with previously published long-term results measuring Intracept outcomes at five years.

The results included 95 patients successfully treated with Intracept across 22 study sites. Patients achieved statistically significant, clinica…

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…

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…

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…

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…

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 …

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…

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…