Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE […]
Stents
Abbott has positive data for Esprit drug-eluting resorbable scaffold
Abbott today announced data supporting its Esprit BTK everolimus-eluting resorbable scaffold system. The company designed Esprit BTK to treat people with chronic limb-threatening ischemia (CLTI), a severe stage of peripheral artery disease (PAD). Abbott said its LIFE-BTK trial met both of its primary safety and effectiveness endpoints. It demonstrated the reduction of disease progression and […]
Cordis applauds Medicare expansion for carotid stenting
Cordis announced today that it supports a new expanded coverage decision from the Centers for Medicare & Medicaid Services (CMS). The expanded CMS coverage widens access to minimally invasive endovascular carotid therapy for patients with carotid artery disease. Cordis develops the Precise Pro Rx carotid stent system for this therapy. In a news release, the […]
FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures
EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system. The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures. According to a news release, all cardiovascular procedures cause the release of particulate debris and air bubbles — […]
Rapid Medical wins Chinese approval for adjustable thrombectomy device
Rapid Medical announced today that it received Chinese approval for its Tigertriever revascularization device for blood clot removal. Yokneam, Israel-based Rapid Medical designed Tigertriever to remove thrombus from delicate brain blood vessels during an ischemic stroke. With National Medical Product Administration (NMPA) approval, it becomes the first device to offer patient-specific solutions for this treatment. […]
Abbott study shows OCT intravascular imaging improves stent procedure outcomes
Abbott announced late-breaking data supporting the use of optical coherence tomography (OCT) imaging. The ILUMIEN IV OPTIMAL PCI study evaluated the use of OCT during percutaneous coronary interventions (PCI). OCT imaging offers additional high-definition images that improve the visualization of vessel structure. This provides doctors with actionable data that translate into patient benefits, potentially shifting […]
BD enrolls first patient in study of stent graft for treating portal hypertension
BD (NYSE:BDX) announced today that it completed the enrollment of the first patient in a trial of its Liverty TIPS stent graft. Franklin Lakes, New Jersey-based BD’s ARCH FDA investigational device exemption (IDE) study evaluates the safety and effectiveness of Liverty. The global, prospective, multi-center, single-arm clinical study looks at the investigational device in the […]
J&J’s Abiomed recalls Impella again — this time it’s TAVR-related
Johnson & Johnson’s Abiomed unit issued another recall for some of its Impella heart pumps. FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from […]
Endologix completes first procedures using Detour system to kick off U.S. launch
Endologix announced today that the first patients underwent a procedure using its Detour system since it received FDA approval. The FDA approved Detour for use in percutaneous transmural arterial bypass (PTAB) to treat peripheral arterial disease (PAD) last month. This initial procedure marks the official start of the company’s targeted market release of Detour in […]
2-year data supports Endologix Detour system for treating PAD
About a week after garnering FDA approval, Endologix announced positive 24-month data for its Detour system for treating PAD. Irvine, California–Endologix picked up premarket approval on June 7 for its Detour system to treat long, complex superficial femoropopliteal lesions. The DETOUR2 study evaluated the system’s performance in percutaneous transmural arterial bypass (PTAB). This approach aims […]
FDA approves new Endologix peripheral arterial disease treatment
Endologix recently announced it received FDA approval for its Detour system to treat long, complex superficial femoropopliteal lesions. Company officials describe the Detour system as a breakthrough in the treatment of peripheral arterial disease (PAD), which the CDC estimates affected roughly 6.5 million Americans over 40. The present recommended therapy is open surgical bypass, an […]
