The global market for products treating heart valve disease is expected to exceed $8bn by 2021, driven largely by the rising number of elderly patients with cardiovascular disease, obesity and growing prevalence of diabetes. This, in turn, is fueling significant innovation in minimally invasive techniques, particularly in the leading area of transcatheter aortic valve replacement (TAVR), but also in transcatheter mitral valve repair (TMVrep) systems, both of which offer patients quicker recovery times, less discomfort and greater safety compared to traditional surgical heart valve repair and replacement. This feature looks more closely at the competitive landscape and dynamics of these two fast-growing market segments, as well as gives insight into what the users – the physicians – think of these technologies.
Heart valve repair is growing, boosted by the ageing population
The global market for products treating heart valve disease is forecast to grow from $4.8bn in 2016 to $8.1bn in 2021, at a compound annual growth rate (CAGR) of 10.9%. According to Meddevicetracker's "Heart Valve Repair And Replacement Market" report, sales of traditional devices used in open heart valve repair and replacement procedures accounted for about 41% of total product sales in 2016, as it gets overtaken by transcatheter technologies – a field currently dominated Edwards Lifesciences Corp., Medtronic PLC and St. Jude Medical Inc. /Abbott Laboratories Inc. – which held 59% of the total market.
By 2021, Meddevicetracker expects new technological advancements and continued expansion to a wider, younger patient population will significantly drive up...
Keep up with the top medtech business and regulatory news.
Medtech Insight brings you interviews and analysis, on the go.
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.
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.
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.
Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.
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.