Abbott has announced that the US Food and Drug Administration (FDA) has approved the Esprit BTK everolimus-eluting resorbable scaffold system (Esprit BTK system), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). The Esprit BTK System is designed to keep arteries open and deliver a drug (everolimus) to support vessel healing prior to completely dissolving. Until today, there were no stents or drug-coated balloons approved for use below the knee in the USA. The standard of care has been balloon angioplasty, which relies on a small balloon d ..read more

The Society of Thoracic Surgeons (STS) has launched new risk calculators covering isolated tricuspid valve repair and replacement, surgical aortic valve replacement (SAVR) after prior transcatheter aortic valve implantation (TAVI), and multi-valve surgery with or without coronary artery bypass graft (CABG) surgery. The STS rolled out all three interactive, mobile-friendly risk calculators in April 2024, adding to its existing portfolio of risk calculators for adult cardiac surgery. “As cardiothoracic surgery continues to evolve, STS has responded by adding new risk models to guide treatment de ..read more

Medtronic has announced the launch of the Avalus Ultra surgical aortic tissue valve. The valve is designed to facilitate ease of use at implant and lifetime patient management, the company said in a press release. “Patients with aortic stenosis are experiencing more complex disease, and therefore, procedures need to evolve to optimise their surgical care,” said Pieter Kappetein, vice president and chief medical officer of the Cardiac Surgery, Structural Heart, and Mechanical Circulatory Support businesses in the Medtronic Cardiovascular portfolio. “Rooted in this evolving need, surgeons are de ..read more

The American Association for Thoracic Surgery (AATS) and the Cardiovascular Research Foundation (CRF) have announced a strategic partnership for CRF’s New York Valves 2024: The Structural Heart Summit (5–7 June, New York, USA), making AATS the cardiothoracic surgical society partner of the meeting. New York Valves is the expanded iteration of CRF’s annual Transcatheter Valve Therapy (TVT) conference. Under this new partnership, AATS and CRF will collaborate on the development of the New York Valves 2024 programme. AATS leaders, David Adams (Icahn School of Medicine at Mount Sinai, New York, US ..read more

Biotronik’s Bülach headquarters Biotronik has announced a multinational distribution partnership with Texray, the developer of a radiation protection textile. In this collaboration Biotronik will distribute Texray’s head and neck protectors starting in selected European and Middle Eastern countries. Both partners aim to raise awareness about the critical importance of radiation protection for healthcare professionals, who serve in environments where radiation exposure is an inherent occupational risk. “Texray’s radiation protective textiles complement Biotronik’s product portfolio, enhancing o ..read more

Concept Medical has announced the commencement of its investigational device exemption (IDE) clinical study, MAGICAL-ISR using the MagicTouch sirolimus drug-coated balloon (DCB), for the management of in-stent restenosis (ISR) in coronary artery disease. MagicTouch had earlier been granted a breakthrough device designation in ISR and later IDE approval by the US Food Drug Administration (FDA). The first patient enrolment was done at the AtlantiCare Institute, Atlantic City (USA), by Said Ashraf and team. The MAGICAL-ISR study aims to assess the safety and efficacy of this sirolimus DCB in trea ..read more

Eric Secemsky presents at CX 2024 “Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Boston, United States) during a late-breaking presentation in this morning’s Peripheral Arterial Controversies programme. Among several presentations on paclitaxel safety, he reported that: yes, the meta-analysis and regulatory body restrictions on paclitaxel-coated devices did cause harm through the relegation of patients to the “less durable” conventional device treatment, increasing the incidence of adverse events post-revascularisation. In a Charing Cro ..read more

Eric Secemsky presents at CX 2024 “Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Boston, United States) during a late-breaking presentation in this morning’s Peripheral Arterial Controversies programme. Among several presentations on paclitaxel safety, he reported that: yes, the meta-analysis and regulatory body restrictions on paclitaxel-coated devices did cause harm through the relegation of patients to the “less durable” conventional device treatment, increasing the incidence of adverse events post-revascularisation. In a session foc ..read more

Tria biopolymer valve Foldax has announced that its Tria valves have surpassed 200 patient life years in human recipients. Patient life years represent the cumulative time the valve has been implanted in patients, offering insight into the duration of its use and its impact on cardiac function over time. Tria valves are intended to improve the lifetime management of heart valve disease in patients. They incorporate a proprietary polymer—LifePolymer—that is used in computer-designed leaflets shown to resist calcification. The novel polymer material enables Tria valves to be robotically produced ..read more

FastWave Medical has announced the issuance of its fourth utility patent by the United States Patent and Trademark Office (USPTO) for its laser-intravascular lithotripsy (IVL) platform. William Nicholson (Emory Healthcare, Atlanta, USA), one of FastWave Medical’s physician advisors, expressed his excitement about the potential for the company’s laser-IVL system, stating: “FastWave’s novel approach has enormous potential to leapfrog today’s IVL technology with durable, fast, and consistent laser energy. It also enables FastWave’s team of engineers to develop an ultra-sleek balloon catheter, ove ..read more