Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold

The Freesolve scaffold. [Image courtesy of Biotronik]Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold.

The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions.

Lake Oswego, Oregon-based Biotronik based its system on the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company says it delivers proven safety, improved deliverability and optimal performance, plus vessel support during and after implantation. Previous data demonstrated 99.6% degradation of magnesium 12 months after implantation into coronary arteries.

In BTK interventions, Biotronik says the Freesolve’s characteristics can offer particular value. In these situations, vessel scaffolding in the short-term resists vessel reco…

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Biotronik, IMDS launch new coronary microcatheter

The Micro Rx microcatheter. [Image courtesy of Biotronik]Biotronik announced that it launched the Micro Rx catheter for enhancing guidewire support during percutaneous coronary interventions (PCI).

Interventional Medical Device Solutions (IMDS) manufactures Micro Rx and Biotronik has exclusive distribution rights. Micro Rx marks the fourth IMDS product brought to the U.S. by Biotronik, joining the NHancer Rx, TrapIT and ReCross catheters.

The Micro Rx catheter features a reinforced distal shaft with a core wire between two layers of braids for optimal push transfer. It has a tapered tip and the market’s smallest tip-leading edge for high-penetration force. The catheter’s proximal-end-stop allows for the seamless integration of a guide extension catheter for additional support, too.

IMDS designed Micro Rx to prioritize user-friendly intervention, eliminating the need for trapping. It could mitigate the risk of vascular trauma during procedures. O…

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Biotronik announces 100,000th implant of ICDs with AFib monitoring

This pacemaker uses DX Technology. [Image courtesy of Biotronik]Biotronik announced today that it hit 100,000 implanted single-lead implantable cardioverter defibrillators (ICDs) with DX Technology.

DX Technology enables direct atrial sensing for AFib detection and monitoring. Since its introduction in 2009, clinicians in more than 80 countries around the world have used DX ICDs.

The technology offers reliable, timely information about atrial arrhythmias and detects AFib early. After detection, DX ICD helps monitor AFib burden over time so clinicians can intervene when needed. They can also react to changes in patient status and optimize treatment.

In combination with Biotronik Home Monitoring, the solution offers a comprehensive assessment of ICD patients. The company says it enables earlier, well-informed decision-making.

Dr. Andreas Hecker, president of CRM/EP at Biotronik, said in a news release that the milestone implant demonstrates the company…

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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 …

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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