Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues

February 16, 2018 By Fink Densford Leave a Comment

Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio.

Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report.

A single patient was reported to have experienced a complication caused by a battery malfunction, which culminated in a battery advisory that was sent to doctors and the redevelopment of battery components, Healio reports.

A total of 33 patients were followed for up to 38 months in the Leadless trial, with a single patient unable to receive the Nanostim device due to a problem.

Survival at three years was reported at 74%, with no deaths reported as being related to the device, according to the report.

The rate of freedom from serious adverse events was reported at 89.9% at 40 months, with three patients experiencing device-related complications, according to Healio.

One patient had a reported procedure-related perforation leading to cardiac tamponade, another had an inadvertent placement of the device through a patent foramen oval leading to removal and re-implantation, while the last had a battery malfunction at 37 months that caused loss of communication, with the device being removed and replaced, according to the report.

No incidents of late device dislodgements, device infections or pacemaker syndrome were reported, and at three years electrical performance of the device was reported as being adequate, Healio reports.

“The overall [leadless cardiac pacemaker] complication rate of 10.1% is comparable to previous reports of transvenous pacemaker complications. Development of a new battery should resolve [the battery malfunction] issue. The adequate performance and freedom from [serious adverse device effects] at midterm follow-up in this first-in-humans patient cohort support the use of leadless pacing as an alternative to transvenous pacing, especially considering the promise of decreasing long-term pacemaker complications,” study author Dr. Fleur Tjong of Amsterdam’s AMC Heart Center said, according to the report.

Only a Few More Days to Register for the most anticipated conference of the winter!

DeviceTalks West is just a few days away. Join more than 300 of your peers for a day of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.

Don’t miss out on this premier opportunity to come together and share perspectives with the best of the best in the industry.

REGISTER NOW

Use code LASTCHANCE to save an additional 20%.

Renerva lands $2.4 million to develop ‘Neosporin of nerve repair’
Nerve-repair startup Renerva said today it has received $2.4 million in funding from the U.S. Department of Defense. The Pittsburgh company is developing a periheral nerve matrix (PNM), an injectable gel derived from porcine tissue to help repair and regenerate injured peripheral nerves. The Medical Technology Enterprise Consortium (MTEC) Award award will enable Renerva to complete its preclinical… […]
Here’s how Intuitive Surgical is innovating to stay competitive
Intuitive Surgical (NSDQ:ISRG) isn’t resting on its laurels when it comes to the surgical robotics field that it dominates. The Sunnyvale, Calif.–based company is seeking to stay competitive through technologies including computer-controlled navigated robotic catheters, contrast agents to improve imaging during procedures, and intelligent surgical interfaces. That was a big message that hundreds of attendees heard during… […]
Will Acelity go public again?
Privately held Acelity may go public again, according to news reports this week. London-based Apax Partners and a pair of Canadian pension funds acquired wound-care company Kinetic Concepts Inc. (now Acelity) for $6.1 billion in a leveraged buyout in 2011. Apax is now mulling an initial public offering for Acelity by mid-2019, Bloomberg and the San Antonio Express-news reported.… […]
Okay Industries hires director of application development
Okay Industries announced that it has appointed John Kollar as the new director of application development. He will be based at the company’s New Britain, Conn. headquarters. Kollar will be responsible for supporting product engineering and development, as well as leading the expansion of the company into plastic molding capabilities. “We are excited to welcome… […]
Qosina launches e-commerce website redesign
Qosina has launched a newly redesigned e-commerce website that improves navigation and access. The company announced that the new website offers easier access to Qosina’s products and services. It features an updated product category structure, category-specific filtering to find components easily and downloadable documentation like safety data sheets, technical data sheets and compatibility information. “Our… […]
All Sensors adds pressure ranges to its compact sensor series
All Sensors (Morgan Hill, Calif.) said it has introduced additional pressure ranges to its BLC series. Applications for the series include medical devices, medical instruments and portable/hand held devices. The series now includes high-pressure ranges from 5 psi to 150 psi, offering design engineers performance for pressure ranges of ±1 inH2O through ±30 inH2O, and now 5 psi… […]
Synopsys releases new version of Simpleware
Synopsys (Mountain View, Calif.) has released a new version of its Simpleware 3D data visualization software, which is used in both life science and advanced materials and manufacturing applications. Improvements in the new Simpleware (Version O-2018.12) include: An intelligent number formatting system for better clarity of measurements and statistics. Refreshed icons for more efficient navigation of… […]
Solar Atmospheres hires new sales manager
Solar Atmospheres recently announced that it has hired Mike Paponetti as a sales manager at the company’s South Carolina facility. Paponetti will be responsible for leading sales efforts to maintain and promote sales for Solar Atmosphere in the Southeastern U.S. Prior to joining Solar Atmospheres’s South Carolina facility, Paponetti was regional sales manager at the… […]
Excelitas Technologies to buy Axsun Technologies
Excelitas Technologies (Waltham, Mass.) – a global provider of high-performance photonics – said today that it has signed a definitive agreement to acquire Axsun Technologies. Axsun (Billerica, Mass.) is a privately-held company that develops and produces MEMS-based light engines for high-performance medical imaging and industrial spectroscopy applications. Financial terms of the agreement were not disclosed. The deal… […]
November 2018 Special Edition: Women in Medtech
Lessons learned from top women leaders in medtech According to the Center for American Progress, women account for 47% of the country’s labor force and 52% of all professional-level jobs. The Equal Employment Opportunity Commission reports that just 20% of U.S. high-tech executives, senior officers and management are women, including pharmaceutical and medicine manufacturing and… […]
121nexus rebrands as Soom
121nexus recently announced that it is rebranding to Soom. As part of the rebranding, the company is also going to exclusively focus on the healthcare industry in its services. “Soom, meaning ‘breath,’ encapsulates all that the company stands for. Like a breath of fresh air, we’re rethinking how the healthcare industry uses proven technologies like… […]