Cardiology

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

The results from a trio of studies show that AI-powered digital stethoscopes are effective at identifying patients at elevated risk of experiencing heart attacks and other major cardiac adverse events, according to Eko Health, whose technology was used to screen the participants in the studies.

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.

Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.

Tim Schmid, executive VP and worldwide chairman of J&J MedTech, expects Shockwave, acquired in April, and Abiomed, purchased in late 2022, to be “long-term gems” for the company. Cardiovascular is among higher-growth segments where J&J has concentrated investments in recent years, along with robotic surgical systems.

According to Zacks Equity Research, the new trial seeks to support AlphaVac’s adoption in the European market, where pulmonary embolism prevalence and severity is an estimated 435,000 events annually.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Leaders from Eli Lilly and Vertex Pharmaceuticals, 9amHealth, Features Capital, and accelerator PharmStars discussed the convergence of biopharma, medtech and healthtech, and what is needed to achieve health care transformation, in an LSX World Congress USA panel.

The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

With the reversal of the Chevron doctrine in June, lower courts will now have more say in deciding regulatory statutes when the language is murky. But will that open the door to more legal challenges from the healthcare industry against government regulations it finds unfavorable? A pair of legal experts recently discussed the potential implications of the Court’s decision.

A key differentiating feature between Medtronic’s Aurora extravascular ICD and Boston Scientific’s Emblem subcutaneous ICD, Aurora’s anti-tachycardia pacing was successful 77% of the time, in line with transvenous ATP rates, and shocks were avoided in nearly half of spontaneous arrhythmic episodes due to the availability of ATP, across average pivotal trial follow-up of 30.6 months. 

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

Renata Medical has received US FDA clearance for its Minima Growth stent, which is designed for neonates, infants and young children and built to expand as the patient ages.

This week, Illumina announced its new CDx has FDA approval; GE and Boston Scientific nabbed CE marks; and the FDA’s Patient Engagement Advisory Committee announced that its October meeting will focus on informed consent in clinical trials.

The EU IHI’s eighth call for action also encourages innovative medtech approaches to tackling cardiovascular disease and osteoarthritis and patient-centered endpoints that can benefit from advancements in digital health.