Zoll Medical Archives - Medical Design Sourcing

FDA approves Zoll therapy for sleep apnea with MRI

The Remedē EL X sleep apnea therapy. [Image from Zoll]Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI).

Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the system and covers new patients as well as existing ones.

Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute, said in a news release that CSA patients often suffer from other co-morbidities. These comorbidities may benefit from MRI scanning, including brain, spine and joint issues.

Remedē initially received FDA approval in 2017. The implantable device activates automatically each night to simulate the phrenic nerve in the chest. This sends signals to the diaphragm to help restore a more normal breathing pattern.…

Zoll data breach affects more than 1 million people

More than 1 million people may have had personal data compromised during a recent hacking of Zoll Medical’s systems.

That’s according to a notice that Zoll filed with the Main Attorney General, one of a number filed with federal and state agencies since the late January data breach.

Run out of Massachusetts, Zoll is an Asahi Kasei company. It makes a variety of advanced emergency care devices that provide defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, ventilation, and more.

According to an accompanying sample notice that Zoll sent to those affected, the company detected unusual activity on its internal network on Jan. 28. The company engaged in mitigation efforts, consulted with third-party cybersecurity experts, and notified law enforcement.

Within days, Zoll had determined that the data breach could have enabled hackers to gain access to customers’ personal health…

First patient enrolled in Zoll trial for supersaturated oxygen therapy in heart attack patients

[Image from Zoll]Zoll Medical announced that the first patient enrolled in its AMIHOT III post-approval study for its TherOx supersaturated oxygen (SSO2) therapy.

Chelmsford, Massachusetts-based Zoll’s trial will evaluate TherOx for treating the most severe form of heart attack: left anterior descending (LAD) ST-elevation myocardial infarction (STEMI). TherOx is an FDA-approved therapy shown to reduce the size of damaged tissue following percutaneous coronary intervention (PCI).

Zoll’s SSO2 therapy delivers a high concentration of dissolved oxygen directly to damaged heart muscle immediately after stenting. TherOx is indicated for patients who suffer LAD STEMI treated within six hours of symptom onset.

The first patient was treated with SSO2 therapy at WakeMed Health & Hospitals in North Carolina. AMIHOT III will further validate the benefits of TherOx over standard of care along. Aside from safety and effectiveness, additional endpoints inc…

Zoll closes $538M acquisition of Itamar Medical

Zoll Medical announced today that it completed its previously announced $538 million acquisition of Itamar Medical (NSDQ:ITMR).

In September, Zoll confirmed its intent to acquire all outstanding shares of Itamar, a developer of non-invasive devices and solutions for the diagnosis of respiratory sleep disorders, at $31 per American Deposiory Share (ADS), a premium of 50.2% over the price of Itamar’s ADS on the Nasdaq market on Sept. 10.

According to a news release, Israel-based Itamar Medical’s ordinary shares will cease to be traded on the TASE market and the company will no longer have reporting obligations under applicable Israeli securities laws.

Chelmsford, Massachusetts-based Zoll said Itamar will operate as a business division within the company, with Itamar’s CEO, Gilad Glick, to lead the division as President.

Itamar’s principal operations in Caesarea, Israel, will continue with no material changes to operations currently…

Zoll Medical to acquire Itamar Medical in $538M deal

Zoll Medical announced today that it will acquire Itamar Medical (NSDQ:ITMR) for a total value of approximately $538 million.

Chelmsford, Massachusetts-based Zoll will acquire all outstanding shares of Itamar, a developer of non-invasive devices and solutions for the diagnosis of respiratory sleep disorders, at $31 per American Deposiory Share (ADS), a premium of 50.2% over the price of Itamar’s ADS on the Nasdaq market on Sept. 10.

According to a news release, both companies’ boards approved the deal, which remains subject to approval by shareholders of Itamar, regulatory approvals and other customary closing conditions. The companies expect the transaction to close by the end of 2021 and, once completed, they expect that Itamar’s principal operations will continue at its current location in Caesarea, Israel.

Itamar develops the FDA-cleared WatchPAT home sleep apnea device designed for sleep apnea diagnosis for patients and healthcare…

FDA approves Zoll Respicardia’s next-gen Remedē system

The Remedē EL-X implantable neurostimulation system [Image courtesy of Zoll Respicardia]Zoll Medical, an Asahi Kasei company, announced today that the FDA has approved its next-gen Remedē EL-X implantable neurostimulation system to treat severe sleep apnea.

Zoll acquired the technology through its acquisition of Respicardia in April.

Improvements to the new Remedē EL-X include:

40% longer average battery life versus the previous version; Three-fourths the size of the previous version; A single lead, single-port system providing both stimulation and sensing from a single lead; Data-driven clinical insights with Drēam View, which includes full-night, comprehensive diagnostic capabilities.

“The next-generation Remedē system is built on the proven success of the current platform, with the needs of both patients and clinicians in mind,” Pete Sommerness, president of Zoll Respicardia, said in a news release. “The increased longevity, smaller size, enhanced d…

DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?

This week’s DeviceTalks Weekly Podcast guests

In this week’s DeviceTalks Weekly Podcast, Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics.

Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of Zimmer’s ZB edge suite of digital and robotics technologies.

In a separate interview, we talk with Achuta Kadambi, assistant professor at the UCLA Samueli School of Engineering, about a column he contributed to Science suggesting physics may be causing medical devices to perform at varying levels in people of different races.

Kadambi explains his own work in the field and suggests how medical device developers may want to move forward in the future.

See our initial report in Medical Design and Outsourcing here.

Chris New…

Zoll Medical acquires Respicardia

Zoll Medical said today that it has acquired Respicardia and its neurostimulation tech for treating sleep apnea.

The financial terms of the deal were not disclosed.

Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function.

“Zoll and Respicardia both develop innovative therapies for conditions with large unmet clinical needs, and we share a deep commitment to improving patient outcomes,” Zoll Medical CEO Jon Rennert said in a news release. “With this acquisition, Zoll will combine its expertise in cardiac and respiratory care with Respicardia’s novel Remedē System to make a meaningful difference in the health and quality of life for many patients.”

A cardiac electrophysiologist implants Respicardia’s system during a minimally invasive outpatient procedure. It delivers electrical pulses to one of the phren…

FDA says lay rescuers can use Zoll AED 3 defibrillator

Zoll Medical announced yesterday that its Zoll AED 3 defibrillator received FDA premarket approval (PMA) for use by lay rescuers.

Chelmsford, Mass.-based Zoll’s AED 3 defibrillator uses CPR technology with integrated, real-time feedback to deliver guideline-compliant CPR to improve outcomes from sudden cardiac arrest. The company touts its enhanced technology as the first in the industry to offer a full-color display with vivid rescue images, a CPR cycle timer and a color bar gauge that shows CPR compression depth.

The Zoll AED 3 system can treat adult and pediatric patients with one CPR Uni-padz electrode, a five-year, universal CPR electrode that eliminates the need to purchase separate electrode pads for adults and children. The defibrillator also includes cloud connectivity for reporting device status and access to cardiac arrest data for transmitting to medical professionals, according to a news release.

“ZOLL is committed to supporting the pu…