AtriCure is rolling into the new year with some significant milestones that help reinforce the presence it has built in the cardiovascular space. The company has been at the forefront of the space in the past – by receiving significant investor attention for its work in atrial fibrillation (Afib) and left atrial appendage (LAA) management. Back in 2018, AtriCure was f...
Abbott Laboratories has won a nod from FDA for a new alternative surgical technique for the HeartMate 3 Left Ventricular Assist Device (LVAD). This technique will not only allow more advanced heart failure patients the opportunity to avoid open-heart surgery, but it will help advance the firm's position in the LVAD market. Dublin-based Medtronic won the same designat...
The CryoLife (Kennesaw, GA, USA) E-nya thoracic stent graft system is designed to increase treatment options for patients with thoracic aortic disease. The endovascular stent graft system offers both bare spring and covered proximal configurations with tip capture technology, enhancing the control and predictability of the minimally invasive procedure during deployment f...
For many patients on hemodialysis, an arteriovenous (AV) fistula is created to link an artery to a vein. Veins are too fragile for frequent access, but arteries are too deep. Creating an AV fistula makes the vein that is linked to an artery more resilient and capable of providing regular vascular access for dialysis. While effective, and a standard of care for ESRD pa...
SCHILLER is a globally active medical technology group headquartered in Baar, Switzerland. SCHILLER is a leader in the development and production of devices for heart and lung diagnostics, patient monitoring, rescue medicine and defibrillation. SCHILLER develops and manufactures the latest technologies in Baar and in its European competence centers. www.schiller.ch
Results were presented on the podium at the 2019 Vascular InterVentional Advances conference (VIVA; 4–7 November, Las Vegas, USA) by Daniel Clair, PROMISE II principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Palmetto Health-USC Medical Group. “Findings from this early feasibility trial are very promising,” said...
This prospective, multicentre, single-arm global pivotal study was designed to investigate the safety and effectiveness of the Tack endovascular system (Intact Vascular) to repair dissections in below-the-knee (BTK) arteries. Primary safety and efficacy endpoints were analysed at six months and compared with performance goals derived from the critical limb ischemia (CLI)...
The Revolution rotational atherectomy system incorporates continuous aspiration and has a dual indication for atherectomy and thrombectomy. The device is intended for atherectomy of the peripheral vasculature in patients with obstructive atherosclerotic disease both above and below the knee. No capital equipment is required. The spheroid-shaped burr rotates at 140,000 rp...
Technical success was achieved for all intended Nexus introductions and deployments (100%). At 30 days, two (8%) patients died from cardiac causes and two (8%) patients showed nondisabling stroke, which resolved completely within 30 days. During a mean follow-up of 25 months, there was one additional procedure-related mortality from stroke, and one patient was convert...
The study will be conducted in Buenos Aires, Argentina under the leadership of principal investigator Pedro Lylyk and is scheduled to begin enrolment during the first quarter of 2020. “We are delighted to have received ANMAT approval to begin a clinical evaluation of our system. We believe the study design will demonstrate the safety and efficacy of the eShunt procedu...
Shockwave S4 is a low-profile catheter specifically designed to access and treat challenging calcified lesions in below-the-knee (BTK) arteries that are frequently associated with critical limb ischaemia (CLI). “The novel Shockwave S4 IVL catheter has the potential to change the treatment paradigm for our most difficult-to-treat patients—those with non-healing ulcers ...
The news marks the third major geographical launch of the Valiant Navion, following US Food and Drug Administration (FDA) and CE mark approvals in late 2018. The low-profile Valiant Navion system is built to further improve upon the performance of the market-leading Valiant Captivia thoracic stent graft system, which has treated more than 100,000 patients globally, wh...
The safety communication, published on the FDA website on 28 October, stated: “The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm [Type III endoleak] when Endologix AFX endovascular grafts [AFX with Strata, AFX with Duraply, or AFX2] are used for the treatment of [AAA].” The communication continues that the FDA had prev...
The device has been engineered to effectively cover and instantaneously seal off diseased tissue with a higher multidirectional resistance force, providing an endoluminal bypass option for physicians faced with complex lesions. Its design provides high flexibility without compromising the requirement length, balanced radial force and low shortening rate. The pull-back...
The study confirms an increased all-cause mortality, which has formerly been stated, and found a broad heterogeneity in the effectivity of the procedure depending on pre-dilation strategy, lesion complexity, and the paclitaxel density. The authors raise doubts about a class effect of drug-coated balloons and suggest a highly individualised therapeutic decision. This meta...
According to a press release, the new balloons broaden physicians’ treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis and expand the Stellarex portfolio, which has a proven significant treatment effect and high safety profile. The 200mm and 150mm Stellarex 0.035” low-dose DCBs are now available in the USA and will be rolled out ...
To understand the sexual status of post-coronary patients enrolled in an exercise-centered rehabilitation program, researchers collected questionnaires on sexual activity from 161 patients. The wives of 100 of these patients were also administered questionnaires for the study.The wives of these patients with reduced sexual activity reported their husbands being less will...
Previous studies have found women with high blood pressure have about a 15% increased risk of developing breast cancer compared to women with normal blood pressure. High levels of the protein GRK4 (G-protein coupled receptor kinase 4) have been shown to cause high blood pressure, also called hypertension. The new study, presented Friday at the American Heart Association'...
It came down to genes. Using blood samples, researchers looked at more than 12,000 genes and found 438 that acted differently in stroke survivors with cancer. "No one before had differentiated gene expression between patients with cancer, stroke or both," said Dr. Babak Navi, lead author of the study published Thursday in the American Heart Association journal Stroke....
Martin Funovics, Medical University of Vienna, Austria, presented the full-cohort primary endpoint data at the Annual Scientific Meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE 2019; 7–11 September, Barcelona, Spain). BIOFLEX-COF is the first randomised controlled trial (RCT) to investigate differences in clinical outcomes of nit...
The presentation included outcomes of two cohorts—a non-randomised phase 2 (n=30; two international sites, two surgeons) and the open label subset (OL; n=26; 20 U.S. sites, 26 surgeons) of the ACCESS study, an ongoing, randomised controlled, multicentre US phase 3 trial. For the composite study group of 56 patients: 78% and 73% of AVF were suitable for dialysis at six...
On July 30, BriteMED signed the MOU with Hsin Chu Armed Force Hospital and Yuan Ze University Medical Informatics Lab for ECG tele-diagnosis and home medical care program. The cooperation aims to develop the first AI-based 12-lead ECG interpretation algorithm and intelligent diagnosis system in Taiwan. The superintendent Yang Chung Chi expects this system can improve qua...
Traditional urinary catheters have issues draining urine from the bladder, causing inaccurate UO measurements. Using active drain line clearance, the Accuryn® Monitoring System automatically clears the drainage line as needed. Hayward, California – July 15, 2019 – Potrero Medical has received CE mark in the European Union for its technology platform, the Accuryn® Monito...
S.S. White Technologies reports that a custom S.S. White flexible shaft is being used to drive a new Medtronic device for Endovascular Aneurysm Repair (EVAR). The shaft is central to the Heli-FX EndoAnchor System and maneuvers and installs a staple to secure endografts in Abdominal Aortic Aneurysm (AAA) and Thoracic Aortic Aneurysm (TAA) cases, the company reported in a ...
Is there a more effective way to treat patients suffering from deep vein reflux (DVR)? South San Francisco-based InterVene is betting its BlueLeaf Endovenous Valve Formation System, a catheter-based solution, can tackle this unmet need. To help with the development of the BlueLeaf system, the start-up raised $15 million in a series B round. The financing was led by ne...
IDE approval allows the company to initiate a US pivotal clinical trial to evaluate MicroStent’s safety and efficacy. A press release reports that MicroStent is a vascular stent specifically designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limb ischaemia resulting from peripher...
In order to know how a patient is doing post implantation, angiography and MRI are used to image the vasculature, but these don’t give much detail about how well blood is moving through the diverter. A team of scientists has now developed a prototype flow diverter that has a blood flow sensor built in. The device can be implanted just like other existing flow divert...
Made of stem cells carefully differentiated into cardiomyocytes, the patches, which are about the size of a small coin and contain approximately 50 million cells, can expand in size with every contraction. They initially help the heart to compensate for lost pumping power, but hopefully will eventually integrate with the heart and effectively replace the damaged tissues....
Once there, though, getting a catheter tip to the exact spot within the heart that requires treatment can still be exceedingly difficult. Unlike the vasculature used to get there, the heart doesn’t naturally guide the catheter’s path forward and so there’s a need to bend the distal end of the catheter in a very controlled manner so that it ends up precisely where needed...
It's been a turbulent couple of years for Endologix, but as MD+DI reported in February, the company has been working hard to win back customers. During the company's first-quarter earnings call, CEO John Onopchenko shared a story about a physician at an academic medical center in the Western United States (he did not disclose the name of the physician or the center) w...
Now another option, called SuperSaturated Oxygen (SSO2), is being made available thanks to a brand new approval from the FDA. SSO2 is the first treatment approved by the FDA since percutaneous coronary intervention (PCI, aka stenting) to help reduce the damage that heart attacks cause. The therapy, developed by TherOx, a company based in Irvine, California, involves p...
One London hospital to recognize the potential of this promising technology is Charing Cross, which has an active surgical research laboratory. James Duncan, clinical research fellow and the rest of the orthopaedic surgery team were faced with a tricky procedure: the reconstruction of an acetabular – or pelvic – fracture in a man who had had a motorbike accident. The...
In the USA, there are more than 440,000 patients with ESRD who are surviving on haemodialysis, and the company states that the Covera covered stent has been designed to address challenging lesions in the arteriovenous access circuit. The stent is available in both a flared and a straight configuration to allow for precise sizing and apposition to the vessel wall and incl...
The team's research paper, published in Theranostics, focuses on developing a stem cell cardiac patch made with tissue engineered with tiny blood vessels to be like real heart muscled. Their review paper published in Acta Biomaterialia, examines the pros and cons of six innovative strategies for aligning the microvessels in engineered tissues. The vascular system brin...
Cardiologist Rajesh Dash, MD, PhD, directs the Stanford South Asian Translational Heart Initiative (SSATHI), a clinic that focuses on preventing cardiometabolic disease in South Asian individuals, whose risk for this disease is four times higher than other ethnicities. To help his patients adhere to a potentially lifesaving prevention regimen, Dash and his colleagues cam...
In the study, Carlos Galan-Arriola, DVM, with the National Center for Cardiovascular Research in Madrid, and colleagues sought to identify early serial cardiac magnetic resonance (CMR) markers of anthracycline-induced cardiotoxicity. Anthracycline is a popular class of chemotherapy drug and contributes to heart failure in up to 25 percent of patients. Galan-Arriola st...
