Biotronik Archives - Medical Design Sourcing

Biotronik has positive data for its spinal cord stimulation tech

The Prospera SCS system. [Image courtesy of Biotronik]Biotronik today announced positive results from a clinical trial for its Neuro Prospera spinal cord stimulation (SCS) system.

The BENEFIT-02 trial evaluates the Resonance multiphase stimulating paradigm used in the Neuro Prospera system. It looked at the safety and effectiveness of the stimulator in treating patients with chronic pain.

Contrary to other currently available SCS therapies, Resonance requires less power and uses a proprietary integrated circuit design. It delivers a continuous, spatially and temporarily distributed therapeutic pulse pattern across the spinal cord.

Biotronik’s prospective, multicenter, randomized, single-blind feasibility study included participants with chronic low back and/or leg pain. They presented a baseline numerical rating scale (NRS) for overall pain intensity greater to or equal to six. After a successful commercial SCS trial, Biotronik randomized patients to …

Biotronik announces first U.S. implant of next-gen pacemaker

The Amvia and CRT-P pacemaker family. [Image from Biotronik]Biotronik today announced the first U.S. implantation of its new, next-generation Amvia Edge pacemaker system.

The FDA approved the Biotronik portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P) last month. Dr. Raul Weiss completed the procedure at Mount Sinai Medical Center in Miami, Florida.

“I was very pleased to have been a part of the first implant of Amvia Edge. The procedure went well, and I’m excited about the benefits this new device will be able to bring to our patients as well as our practice,” said Weiss. “The ability to eliminate device scans before and after an MRI procedure is a much-needed advancement, and I look forward to seeing how these types of technologies help streamline our workflows in the future.”

More about the Biotronik Amvia Edge pacemaker family

Lake Oswego, Oregon-based Biotronik designed Amvia Edge a…

FDA approves next-gen family of pacemakers from Biotronik

The Amvia and CRT-P pacemaker family. [Image from Biotronik]Biotronik announced today that the FDA approved its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P).

Lake Oswego, Oregon-based Biotronik designed Amvia Edge as the market’s smallest single-chamber MR conditional pacemaker. It offers a set of patient-centric solutions coupled with automated workflow efficiency.

The pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology. It uses always-on, dedicated sensors to automatically recognize a patient’s entrance into an MRI field. The MRI Guard then converts the device to MRI mode and returns to its permanent programming after the scan completes. This eliminates any pre- or post-scan programming needs.

“MRI Guard 24/7 is a solution for real-world challenges, as we strive to improve safety and increase efficiencies for CIED patients who need MRI access,” said Dr. David Haye…

Philips, Biotronik partner to expand care for out-of-hospital cardiology labs

Philips (NYSE: PHG) + today announced a new partnership with Biotronik.

The companies teamed up to expand the range of cardiovascular devices available for Philips SymphonySuite customers. Biotronik develops products and services for treating cardiovascular and endovascular diseases.

Philips designed its SymphonySuite for opening and expanding cardiovascular office-based labs OBLs and ambulatory surgery centers (ASCs). The Amsterdam-based medtech giant says it features a full range of high-performing, highly specialized equipment and devices. It also offers personalized services, financing options, site planning, ongoing operational support and device programs.

“Philips is committed to expanding access to care through its innovative solutions and Biotronik’s alliance adds additional devices, including a cardiac rhythm management portfolio, to SymphonySuite,” said Chris DeCarolis, head of procedural solutio…

How Schurter helped Biotronik develop the Renamic Neo

Biotronik’s Renamic Neo device [Photo courtesy of Biotronik]

Biotronik won FDA approval for its Renamic Neo programmer for implanted cardiac rhythm management devices this year, thanks to some help from an electronic components supplier.

The Lake Oswego, Oregon-based device developer designed the Renamic Neo for implantable cardioverter defibrillators, pacemakers and implantable cardiac monitors. The control unit wirelessly communicates with the implanted device and allows the physician or patient to read out information such as battery status, heart rate and other important parameters. The control unit can also wirelessly program the implant.

The Renamic Neo’s wireless communication relies on a low-power radio signal, so there can be no interference in the signal’s frequency range. Electromagnetic compatibility (EMC) was an important part of the development of the device, which uses co…

FDA approves Biotronik’s self-expanding stent system

The Pulsar-18 T3 self-expanding stent. [Image from Biotronik]Biotronik announced today that it received FDA approval for its Pulsar-18 T3 peripheral self-expanding stent system.

Pulsar-18 T3 combines a 4-French low-profile delivery system with a tri-axial system with a braided shaft design and thin struts with low chronic outward force (COF), creating an improved implantation procedure for endovascular treatments.

According to a news release, the 4-French system may decrease the risk of access site complications and reduce the need for closure devices when compared to 6-French devices. The tri-axial system with the braided shaft facilitates stable and accurate implantation of the Pulsar stent, while the thin struts and low chronic outward force means the Pulsar-18 contributes to a reduced mean area of restenosis.

The company said its redesigned Pulsar-18 T3 stent system offers physicians “an intuitive and ergonomic” wheel-operated handle for one…

Biotronik reaches $12.95M settlement with DOJ over improper payment allegations

Biotronik today agreed to pay a $12.95 million settlement with the U.S. Justice Dept. (DOJ) to resolve allegations that it violated the False Claims Act.

DOJ alleged that the cardiac device maker violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce their use of Biotronik’s implantable cardiac devices, such as pacemakers and defibrillators.

Allegations included overuse of paid consultants on behalf of itself and highly regarded physician partners, according to a Biotroink news release. The company said that the parties — the company, DOJ, the U.S. Attorney’s Office for the Central District of California, and the U.S. Department of Health and Human Services (HHS) — have agreed that the settlement is not an admission of liability.

“The company is pleased to put this investigation behind us so we can continue in our mission to deliver innovative solutio…

FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices

Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices.

Lake Oswego, Oregon-based Biotronik designed its Renamic Neo programmer for implanted devices, including ICDs, pacemakers and implantable cardiac monitors.

Get the full story at our sister site, MassDevice.

FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices

Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices.

Lake Oswego, Oregon-based Biotronik designed its state-of-the-art Renamic Neo programmer for implanted devices including ICDs, pacemakers and implantable cardiac monitors.

According to a news release, Renamic Neo offers LifeSupport for clinicians to share the programmer screen with or grant programmer control to Biotronik technical support personnel at remote locations. It has compatibility with Biotronik’s ReportShare and EHR DataSync to allow for the secure and easy integration of programmer data into hospitals’ EHR systems.

Renamic Neo also has a 12-inch, high-resolution, high-contrast LCD touch screen display, a built-in analyzer and battery-powered portability. The company said the system is also significantly lighter and smaller than the previous iteration. Biotronik will make the platform available in the U.S. soo…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news releas…

The 18 most innovative medical devices of 2020

The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards.

The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition.

“As we celebrate 50 years of the Prix Galien process, we are honored to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

Get the full story on our sister site, Medical Design & Outsourcing.