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How LivaNova developed a next-generation perfusion system

Access to technology, integrated systems and data reign supreme in the new era of perfusion.

By Marco Dolci, LivaNova

LivaNova’s Essenz Perfusion System [Image courtesy of LivaNova]

Perfusionists are essential players on a cardiac surgery team, ensuring patients receive critical clinical support to maintain vital functions during a procedure. In short, the breath and heartbeat of patients’ lives rest in the hands of perfusionists operating a perfusion system, while the surgical team intervenes on the heart.

Today’s perfusionists need connected and real-time data in addition to effective technical and hardware functionality. Their clinical roles are evolving in the operating room (OR) and a new era is emerging in which access to technology, integrated systems, data analytics and actionable information will drive quality, efficiency and continuously improved patient care across all phases of a proce…

LivaNova more than doubles profits in Q1

LivaNova (Nasdaq:LIVN) shares dipped this morning on first-quarter results that topped the consensus forecast.

Shares of LIVN fell 2.4% to $45.98 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 0.5%.

The London-based medtech company posted profits of 7.4 million, or 14¢ per share. It reported sales of $263.4 million for the three months ended March 31, 2023. That translates to a more than doubled bottom line (from profits of $3 million) on sales growth of 9.7%.

Cardiopulmonary revenues ticked up 17.5% thanks to oxygenator revenues, while neuromodulation sales grew 11.1%. LivaNova saw a 15.7% revenue dip in its advanced circulatory support business, however. It attributed that to fewer patients treated with extracorporeal membrane oxygenation (ECMO) as a result of fewer severe COVID cases.

Adjusted to exclude one-time items, earnings …

FDA clears Essenz heart-lung machine from LivaNova

The Essenz perfusion system. [Image courtesy of LivaNova]LivaNova (Nasdaq:LIVN) announced today that it received FDA 510(k) clearance for its Essenz heart-lung machine (HLM).

With clearance, the London-based company initiated its U.S. commercial launch for Essenz, too. It recently received approval for Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In February, LivaNova kicked off a limited commercial launch for Essenz in Europe, too.

LivaNova said in a news release that it now plans to start a broad European launch after success in its limited rollout. The limited launch supported more than 200 adult, pediatric and neonatal patients in Europe.

LivaNova designed the Essenz system with a next-generation heart-lung machine and a patient monitor. The company built it to deliver a patient-tailored approach. This approach supports data-driven decisions during cardiopulmonary bypass (CPB) procedures.

LivaNova grows profits in Q4 results

LivaNova (Nasdaq:LIVN) this week posted fourth-quarter results that beat the overall consensus on Wall Street.

The London-based company reported profits of $1.7 million, or 3¢ per share, on sales of $274.9 million for the three months ended Dec. 31, 2022, for a sales gain of 1.78% compared with Q4 2021. It also had a profit gain over the same quarter in 2021 when it reported profit losses of $5.1 million.

Adjusted to exclude one-time items, earnings per share were 81¢, 8¢ ahead of The Street, where analysts were looking for sales of $262.58 million.

“We delivered revenue growth across all regions in the fourth quarter, excluding foreign currency impact, led by our Cardiopulmonary and Neuromodulation business units,” CEO Damien McDonald said in a news release. “In 2023, we remain committed to executing on our core growth drivers, delivering on clinical and product pipeline opportunities, and driving operating leverage to improve cash flo…

LivaNova starts limited European launch of perfusion system for cardiopulmonary bypass

https://www.massdevice.com/wp-content/uploads/2023/02/First_CPB_Essenz_-_External.mp4 The Essenz perfusion system. [Image courtesy of LivaNova]LivaNova (Nasdaq:LIVN) announced today that it began a limited commercial release for its Essenz perfusion system in Europe.

The company initiated its launch in select centers throughout Europe after successful implementation in The Netherlands and Italy.

London-based LivaNova built the Essenz system with a next-generation heart-lung machine and a patient monitor. The company designed it to deliver a patient-tailored approach that supports data-drive decisions during cardiopulmonary bypass procedures.

Catharina Hospital in Eindhoven, The Netherlands carried out the first clinical cases with Essenz. San Donato Hospital in Milan, Italy represented the other European center to kick off the launch. Eddy Overdevest, a perfusionist at Catharina Hospital, said Essenz creates “a new era” of personalized care. Read more

LivaNova launches implantable pulse generator for treating epliepsy

The SenTiva Duo VNS Therapy system. [Image courtesy of LivaNova]LivaNova (Nasdaq:LIVN) announced today that it launched its SenTiva Duo implantable pulse generator (IPG) for providing VNS Therapy.

SenTiva Duo received FDA 510(k) clearance. LivaNova has made it available in the U.S.

The London-based company designed its VNS Therapy as a unique approach for treating drug-resistant epilepsy. Vagus nerve stimulation (VNS) can prevent seizures before they occur and stop them if they do, the company says. The neuromodulation system offers safety and effectiveness as an add-on treatment in adults and children as young as four with partial-onset seizures.

LivaNova said the system’s dual-pin header distinguishes it from the original SenTiva, which came in a single-pin format. Those originally implanted with a dual-pin lead and IPG can receive the benefits of the company’s latest VNS Therapy technology. VNS Therapy patients can replace their device withou…

LivaNova LifeSparc ACS pump cleared for extended use

LifeSparc includes a sterile, on-patient pump. The reduced circuit surface area decreases inflammatory response and eliminates the need for a heater/cooler. [Image courtesy of LivaNova]LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO).

The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic.

In a news release posted yesterday, London-based LivaNova said it used existing real-world evidence to receive the new indication. The evidence included data collected during the pandemic.

“The onset of the global pandemic elevated ECMO to the forefront as an effective treatment option for patients in need of emergent rescue who had limited, if any, options,” said Dr. Raymond Yau, director of Cardiogenic Shock at the Heart H…

BD exec Brooke Story joins LivaNova board as new director

LivaNova (Nasdaq:LIVN) announced today that its board of directors appointed Brooke Story to its board as a new director.

Story currently serves as worldwide president, integrated diagnostic solutions at BD (NYSE:BD). Her appointment to LivaNova’s board is effective today, Sept. 15, 2022. She will also be a member of the board’s nominating and corporate governance committee.

The industry veteran joined BD in her current role in April 2021. Before that, she spent 15 years at medtech giant Medtronic across a range of roles. Prior to her departure, she held the role of president of Medtronic’s pelvic health and gastric therapies. She also spent time early in her career in sales at Johnson & Johnson.

“Over the course of her career, Brooke has excelled in helping large medical device corporations inspire their teams, mentor and develop talent, and deliver economic value,” said William Kozy, chair of the LivaNova board. “Her insight will …

LivaNova stock dips on Q2 results, slashed EPS forecast

LivaNova (Nasdaq:LIVN) shares were down before hours today on second-quarter results that topped the consensus forecast.

The London-based company posted profits of $16.4 million, or 30¢ per share, on sales of $254.2 million for the three months ended June 30, 2022, for a massive bottom-line gain out of the red on a sales decline of 3.9%

Adjusted to exclude one-time items, earnings per share were 53¢, 1¢ ahead of Wall Street, where analysts were looking for sales of $245.5 million.

Revenues in LivaNova’s cardiopulmonary business increased 6.7% year-over-year, driven by oxygenator sales as a result of an increase in cardiac surgery procedures. Neuromodulation sales improved by 0.1%.

Advanced circulatory support revenue decreased 29.6% due to a reduction in patients treated with extracorporeal membrane oxygenation (ECMO) related to fewer severe COVID-19 cases and hospital staffing challenges, partially offset by growth in non-COVID-19 cases, ac…

LivaNova launches patient monitor for cardiopulmonary bypass procedures

Livanova (Nasdaq:LIVN) announced today that it began the commercial launch of its Essenz patient monitor.

London-based LivaNova launched the Essenz patient monitor, which uses a patient-tailored approach to improve efficiency and quality of care during cardiopulmonary bypass (CPB) procedures, in the U.S. and Europe, having recently received both FDA 510(k) clearance and CE mark approval.

The company began the initial targeted launch in U.S. and European hospitals that were involved in the platform’s design and development program, according to a news release.

LivaNova said it designed the patient monitor to provide decision-making support for the perfusionist during the entire CPB procedure with compatibility with the LivaNova S5 heart-lung machine. It will be a feature of the complete Essenz perfusion system as well, which the company expects to launch in stages later this year.

Features of the Essenz monitor include intraoperative quality …

LivaNova implants first patient in Osprey obstructive sleep apnea study

LivaNova (NSDQ:LIVN) announced that it completed the first patient implant in a study of its LivaNova aura6000 system.

London-based LivaNova designed the aura6000 system to maintain muscle tone of the tongue and upper airway so that airway obstruction and resulting sleep apnea are significantly reduced or eliminated. The hypoglossal neurostimulator system includes a programmable, rechargeable and implantable pulse generator (IPG) implanted in a subcutaneous pocket near the patient’s clavicle during an outpatient procedure.

The IPG generates mild stimulation that is delivered via lead to the hypoglossal nerve, stimulating the patient’s tongue during sleep to keep the airway open as an alternative to the traditional CPAP machine, according to a news release. The company said the aura6000 system allows patients to sleep without being connected to masks, hoses or mouthpieces.

LivaNova is conducting the Osprey FDA investigational device exemption …

LivaNova stock up on Street-beating Q4

LivaNova (Nasdaq: LIVN) today reported fourth-quarter results that beat the consensus forecast on Wall Street, with sales expected to grow in 2022.

The London-based cardiac surgery and neuromodulation device company lost $5.1 million, or 10¢ per share, off $270.1 million in sales for the quarter ended Dec. 31, 2021 — versus a loss of $281.1, or $5.78 per share, off $269.6 million in sales during Q4 2020.

Adjusted to exclude one-time items, earnings per share were 57¢, a nickel ahead of The Street, where analysts were looking for EPS of 52¢ on sales of $267.2 million.

“Our execution during the fourth quarter delivered results that met or exceeded the high end of full-year guidance,” CEO Damien McDonald said in a news release.

“Neuromodulation sales grew across all regions benefiting from replacement procedures, and Cardiopulmonary sales improved year over year, driven by oxygenator sales. We maintain our commitment to realize oper…