The clinical requirement to monitor atrial fibrillation (AF) for preventing potential strokes may present a challenge in patients with standard single-chamber implantable cardioverter-defibrillators (ICDs).1 These devices lack the recommended capability to effectively monitor AF,2 which could lead to missed opportunities for timely intervention and stroke prevention.1  DX Technology, a single-lead ICD system equipped with a floating atrial dipole, overcomes this limitation by enabling AF detection and monitoring, even in patients not indicated for a dual-chamber ICD. This advancement spares these patients from an atrial lead implantation while allowing clinicians to assess and reliably monitor AF burden and disease progression over time.Earlier this year, a team of leading experts published the MATRIX study – shedding light on the importance of remote monitoring and on the role of DX Technology in the diagnosis and treatment of AF. We interviewed Dr. Ignasi Anguera Camos from Bellvitge University Hospital, Hospitalet de Llobregat, in Barcelona, Spain, one of the study authors, to discuss key findings and how the DX ICD, combined with remote care, is shaping the future of clinical practice. As we observe Atrial Fibrillation Awareness Month, there's no better time to share these valuable insights and help raise awareness about this intricate condition.Accurate AF Detection and Disease Progression Monitoring“We have been successfully implanting devices with DX Technology for more than ten years now. The recent results of the MATRIX study confirm what we have experienced over the years – a high detection accuracy of AF without the need for a dedicated atrial lead,” says Dr. Anguera. “The key result [of the MATRIX study] is that this device is able to detect what's going on in the atrium with high accuracy, with detection of very high amplitudes of the right atrial signal, a detection which is very stable over time,” explains Dr. Anguera, adding that, “in the end, the patients were effectively monitored [via HomeMonitoring] more than 90 percent of the time.” The quality of AF detection is made possible with good P-wave sensing. Namely, the MATRIX study investigators rated atrial signal detection quality as excellent, good or adequate in more than 95% of cases – at enrollment, at 12-month and at 24-month follow-ups.3“What's even more impressive is the high positive-predictive value (PPV) for detecting atrial high-rate episodes (AHREs) of longer duration, reaching an astounding 99.7% for episodes lasting one hour or more. This enables reliable remote monitoring of subclinical AF, allowing clinicians to monitor disease progression over time, initiate treatment and tailor treatment plans accordingly,” concludes Dr. Anguera. Time to Reconsider Device SelectionFurther on, the MATRIX study showed that the new-onset AHRE, as detected by the DX ICD system and Home Monitoring, is not rare. Within the two years of follow-up, 8.2% of patients without a former history of AF experienced new-onset AHRE, and 31.1% of them a progression to a stratum of longer duration (for example from 6 min–1 hr to 1 hr–24 hrs).3“For me, it's important to truly and efficiently detect incident Afib in our ICD patients. In the study, not only Afib was detected in 8.2 percent of the patients, but we also saw that one out of three patients with [subclinical] Afib had a progression in the type of Afib, from seasonal to persistent or from short episodes to long episodes. There is a progression of the type of arrhythmia in a substantial number of patients. That's why it matters to continuously detect the atrial rhythm,” explains Dr. Anguera.“The MATRIX study results validate the reliability of the signals and the overall stability of the system,” elaborates Dr. Anguera, adding that the observed incidence of new-onset AF reaching 8% cannot be disregarded. “Perhaps it's time to reconsider our device selection strategy, and these results could be an indication that we should simply implant fewer standard single-chamber devices – opting for the DX ICD system more frequently,” he concludes.AF Burden as Key Factor in Treatment Decisions, but More Research NeededOne major reoccurring question that still arises is whether to initiate anticoagulation for patients with AF episodes. “Currently, there is no definitive unison answer regarding the specific threshold for initiating anticoagulation,” says Dr. Anguera.Beyond the duration of individual episodes, the overall burden of AF plays a pivotal role in treatment decisions. “Having an isolated episode of AF in a year differs significantly from experiencing multiple episodes. Unfortunately, the impact of AF burden on AF management remains inconclusive, prompting ongoing trials to address this crucial question. Personalizing decisions based on factors like the patient's CHA2DS2-VASc risk profile and the actual AF burden, thanks to the information from the device, becomes essential,” argues Dr. Anguera. "And while this question awaits an answer, we remain hopeful that the MATRIX study has shed some more light on the potential of AF remote monitoring and detection possibilities for ICD patients, as recommended by the current ESC guidelines."__________________________________________________________________________________If you are interested in more research on AF management, check out our related blog stories. Note: The content of this blog is based on research findings and should not replace individualized medical advice. It is recommended that you consult with a health care professional for personalized guidance and treatment decisions.References:1. Reinhold T, Belke R, Hauser T, et al. Cost Saving Potential of an Early Detection of Atrial Fibrillation in Patients after ICD Implantation. BioMed Research International, Volume 2018, 14 August 2018, Article ID 3417643.2. Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C et al. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the task force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 2021;42:373–498.3. Hindricks G, Theuns DA, Bar-Lev D, et al. Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole, EP Europace, Volume 25, Issue 5, May 2023, Pages 1–10, euad061.

BIOTRONIK announced the two-year-results from the BIOLUX P-III BENELUX all-comers registry, presented by Principal Investigator Prof. Frank Vermassen at CIRSE 2023 in Copenhagen, Denmark.1 The prospective, international, multicenter post-market registry evaluated the safety and efficacy of the Passeo®-18 Lux® drug-coated balloon (DCB) catheter in isolated popliteal artery lesions. This indication is considered a difficult vessel bed to treat due to its biomechanical constraints that usually preclude the placement of stents.BIOLUX P-III BENELUX registry enrolled 99 patients in Belgium, the Netherlands, and Luxembourg with Rutherford 2-5 disease and at least two centimeters of healthy vessel segment between lesions in the popliteal artery and lesions in the distal superficial femoral artery. All patients were treated with the Passeo-18 Lux DCB. The bail-out stenting rate was 14%.At 24 months:Freedom from clinically driven target lesion revascularization (CD-TLR)2 was 81.6%Freedom from major target limb amputation was 98.0%Freedom from all-cause of death was 89.4%Significant improvement of Rutherford classification was observed for 88.1% of the patients“We face a scarcity of data evaluating endovascular therapy for isolated popliteal artery lesions, known as a difficult vessel bed to treat as we don’t want to leave anything behind,” said Principal Investigator Prof. Frank Vermassen, Chief of Vascular and Thoracic Surgery at UZ Ghent in Ghent, Belgium. “It is encouraging to see that we can safely and effectively treat these lesions with a DCB-only approach.”“BIOTRONIK is proud to be a leader in research of paclitaxel-coated balloons, striving to study device performance in the most challenging anatomy and patient characteristics,” said Stuart Perks, Vice President of Marketing, Vascular Intervention at BIOTRONIK. “We repeatedly see the safety and effectiveness of Passeo-18 Lux DCB demonstrated in a diverse range of clinical presentations.”-END- References: 1 Vermassen F. A prospective, international, multi-centre, post-market all-comers registry to assess the clinical performance of the Passeo-18 Lux DCB in isolated popliteal arteries – BIOLUX P-III BENELUX. Presented at: CIRSE 2023; September 9-13, 2023; Copenhagen, Denmark.2 CD-TLR is defined as any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.Passeo and Lux are trademarks or registered trademarks of the BIOTRONIK Group of Companies.Passeo-18 Lux paclitaxel-releasing PTA balloon catheter is not available for sale or use in the United States .  For more information: BIOTRONIK Passeo 18 Lux - Drug-Coated Balloon Catheter 

 As a company whose main mission is to save and improve lives around the world, BIOTRONIK is no stranger to being of service and helping to create a better world. But alongside our responsibility to patients and the medical community, we also have a responsibility to the local, regional, and national communities where we operate.  That’s why BIOTRONIK offices around the world make a point of engaging with local charities and initiatives – to help improve the communities in which we’re based. As we mark Charity Day on September 5th, we’re mindful that supporting our local communities means being integrated in them. In addition to the support Berlin Headquarters gives to initiatives such as supporting underprivileged children through organizations like Die Arche, our local and regional offices around the world are empowered to support initiatives close to them and their hearts. Showing Heart in Portland  As one of BIOTRONIK’s most active offices, US HQ in Portland, Oregon also brings its energy to several local and state-level initiatives through financial support and employee volunteer time – through its Corporate Compass Campaign. “We chose to support the American Heart Association (AHA) and the Merry Heart Children’s Camp because both organizations have missions similar to ours – improving the lives of patients with heart-related conditions,” says Heather La Bore, Training Director at BIOTRONIK in the US. Every year, dozens of BIOTRONIK colleagues from the Portland office join the AHA Heart and Stroke walk in Portland. Walkers raise funds to support the American Heart Association’s work and research into cardiovascular disease, with BIOTRONIK’s Portland office also kicking in support. The Portland team also regularly lends both extra hands and sends funds for the AHA annual Heart Ball. “The money raised through these events help fund AHA’s mission to improve the cardiovascular health of the American population,” says La Bore. Meanwhile, the Merry Heart Children’s Camp is a five-day, four-night summer camp that provides a safe experience specially focused on children and youth with heart conditions. Campers typically come from Oregon, Washington and Idaho and benefit from a fun summer camp experience with specially trained staff. BIOTRONIK Inc. and its employees support Merry Heart both through funds and volunteer time – whether during the camp’s annual fundraising dinner and auction, camp registration, or a “show and tell” session with campers that helps them to understand their devices – if they have them. La Bore also highlights the company’s work in the Feeding America campaign, where US-based employees organize an office contribution to collect both non-perishable food items and funds for local food banks.  A small donation with a big impact in South Africa It started with the donation of a single BIOTRONIK device. Now, the Revived Pulse Foundation – supported by BIOTRONIK South Africa – is donating around 10 to 20 devices a year to patients without health insurance coverage. “In 2013, Revived Pulse Foundation founder Faan Botha was diagnosed with severe heart failure and had to receive a CRT-D device implantation. Unfortunately, his medical insurance declined to pay for the device and we, in collaboration with the hospital team, decided to donate the device to Faan as it was a matter of life and death,” says BIOTRONIK South Africa Guateng North Regional Manager Leon Nel. “The gratitude he felt for this led to the birth of Revived Pulse Foundation in 2018 – to try and help others in need as well. The foundation is well set up to help patients in desperate need and we continue to collaborate with Revived Pulse to help do that.” BIOTRONIK South Africa continues to support Revived Pulse through device donations and help during fundraising events. Botha also plans to gradually expand the numbers of patients Revived Pulse can help. You can read more about his journey in an earlier piece here.  BIOTRONIK Czechia and preserving dignity into old age  In a partnership based on shared values, BIOTRONIK’s Czech office in Prague has partnered locally with Sue Ryder, a charity that helps provide high-quality care to the elderly when just a little extra support is required to help deal with some of the challenges of aging. Sue Ryder helps provide both clients and their families with counselling, residential care and personal assistance, and even equipment when necessary. If needed, it helps arrange home visits or even personalized expertise to seniors and their families, with a view to maintaining dignity in aging – even when a bit of extra help is needed. “It’s an organisation that brings quality, individual attention, and expertise to elderly people and their families,” says BIOTRONIK Czechia’s Magdalena Bockova, who says the Prague office has been providing Sue Ryder with financial donations for three years. “In particular, our donations have helped maintain an interdisciplinary team that includes doctors, nurses, psychologists, nutritionists, and even chaplains – to ensure that every senior can receive the best possible professional care.”  These examples from our colleagues from around the world show that it sometimes doesn't take much to make a difference – just a good idea & motivated colleagues who are willing to lend a hand. We would like to thank all BIOTRONIK supporters for their commitment and dedication! ___________________________________________________________________________________For more information about Corporate Social Responsibility at BIOTRONIK, check out our website. If you’re interested in learning more about BIOTRONIK, read more insightful interviews and articles in our corporate blog.

New data from the BIOMAG-I first-in-human trial shed light on the vascular healing process following the implantation of DREAMS 3G, BIOTRONIK’s third-generation resorbable magnesium scaffold (RMS). A detailed intravascular optical coherence tomography (OCT) analysis demonstrated that 99.3% of the struts completely degraded at one year.1 Dr. Masaru Seguchi from the German Heart Centre in Munich, Germany presented the findings at the European Society of Cardiology’s (ESC) congress in Amsterdam.While earlier BIOMAG-I study results provided favorable outcomes with regards to late lumen loss at six and 12 months,2,3 the additional analysis assessed the 12-months vessel healing profile. The analysis included patients from the multicenter BIOMAG-I trial who underwent OCT imaging pre- and post-procedure, at six and 12 months. One year after implantation of DREAMS 3G RMS, the strut degradation rate was 99.3% as measured by OCT.“We aimed to investigate the scaffold’s resorption process during the initial phase of vessel remodeling,” commented Prof. Dr. Michael Joner, Deputy Director of Cardiology at the German Heart Centre in Munich, Germany. “The degradation results indicate that vascular healing following DREAMS 3G implantation appeared to be nearly complete at 12 months.”Also at the ESC congress, Prof. Dr. Michael Haude, BIOMAG-I Study Coordinating Clinical Investigator, presented another aspect of the trial. His research group investigated vasomotion after Acetylcholine (ACH) and Nitroglycerine (NTG) in 14 patients at the 12-month follow-up after device implantation. The assessment showed that vasomotion returned at one year in all tested patients.4“The return of vasomotion indicates that the scaffolded vessel segment has been uncaged,” explained Prof. Dr. Georg Nollert, Vice President Medical Affairs, Vascular Intervention at BIOTRONIK. “This supports our aim to offer a resorbable scaffold that disappears over time and leaves nothing behind but a healed vessel.”– END –References1 Seguchi M., BIOMAG-I: Twelve-months vessel healing profile following the novel resorbable magnesium scaffold implantation: an intravascular OCT analysis of the BIOMAG-I trial, presented at ESC 2023.2 Haude M., Safety and Performance of a Sirolimus Eluting Resorbable Coronary Magnesium Scaffold (DREAMS 3G): The BIOMAG-1 FIH Trial”, presented at TCT 2022, ClinicalTrials.gov: NCT 041571533 Haude M., BIOMAG-I: One-year clinical outcome of the resorbable magnesium scaffoldDREAMS 3G, presented at EuroPCR 2023.4 Haude M., BIOMAG-I: A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3G): 12-month results of the BIOMAG I first in human study, presented at ESC 2023.BIOmag and DREAMS are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.

BIOFLOW-DAPT one-year-data demonstrated non-inferiority and a good safety profile for the Orsiro® Mission drug-eluting stent (DES) compared to Resolute Onyx DES (p<0.0001) in patients at high risk of bleeding receiving short dual antiplatelet therapy (DAPT). Prof. Marco Valgimigli presented the novel data in a late-breaking trial session at the European Society of Cardiology’s (ESC) Congress in Amsterdam. The results were published simultaneously in Circulation.BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study to assess the safety of one-month DAPT in subjects with high bleeding risk. 1,948 patients were randomized 1:1 to percutaneous coronary intervention (PCI) with either Orsiro Mission or Resolute Onyx DES. Patients were treated with DAPT (aspirin and a P2Y12 inhibitor) for one month, followed by single antiplatelet therapy. Clinical follow-up visits were scheduled at one-, six- and 12-month post-procedure1. The primary endpoint was a composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis evaluated at 12 months. It was observed in 3.6% of the Orsiro Mission group and in 3.4% of the Resolute Onyx group (risk difference, 0.2 percentage points; upper boundary of the one-sided 95% confidence interval (CI), 1.8%; non-inferiority margin, 4.1%; p<0.0001 for non-inferiority).1 “Until recently the data on the performance of Orsiro stent in patients at high bleeding risk undergoing one-month DAPT was limited to observational studies,” stated Prof. Dr. Marco Valgimigli, Deputy Chief of Interventional Cardiology at the Instituto Cardiocentro Ticino, Lugano, Switzerland. “The results show us that a PCI-strategy with biodegradable-polymer sirolimus-eluting stents like Orsiro Mission followed by 30 days of DAPT is non-inferior to durable-polymer zotarolimus-eluting stents in these patients.”  Prolonged DAPT treatment increases the risk of bleeding after PCI. A reduction of bleeding after PCI is of major interest to patients as has a strong relationship with subsequent all-cause mortality and major adverse cardiovascular events.2  “Not only do the results add to the growing body of evidence within our extensive Orsiro DES family clinical program,” said Prof. Dr. Georg Nollert, Vice President Medical Affairs, Vascular Intervention at BIOTRONIK. “They also suggest that one-month DAPT following PCI with Orsiro Mission DES can be considered a safe approach to reduce bleeding risks in these high-bleeding risk patients.”-END- Orsiro Mission DES is not indicated for one month of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. Please refer to the IFU for indications and post-procedure antiplatelet therapy recommendations. Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.  References: 1 Valgimigli, M. BIOFLOW DAPT - Biodegradable polymer SES versus durable polymer ZES in HBR subjects with 1-month DAPT. Presented at: ESC Congress 2023. August 25, 2023. 2 Safety of 3‐Month Dual Antiplatelet Therapy After Implantation of Ultrathin Sirolimus‐Eluting Stents With Biodegradable Polymer (Orsiro): Results From the SMART‐CHOICE Trial, Journal of the American Heart Association. 2021;10:e018366 For more information, visit: Orsiro Mission Drug-Eluting Stent