As TAVI Advances, Adjunctive Devices Multiply

As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need.

The Food and Drug Administration’s (FDA) approval of Edwards Lifesciences Corp.’s Sapien transcatheter aortic heart valve device in early November was certainly a landmark occasion for the US cardiovascular device industry. But the move was so widely anticipated, it was already old news by the time the Transcatheter Cardiovascular Therapeutics (TCT) conference rolled around less than a week later. At TCT, US physicians were treated to a number of detailed sessions on how to set up and operate a transcatheter aortic valve implantation (TAVI) program at their hospitals, with an emphasis on collaboration between multidisciplinary teams of physicians (including interventionalists, heart valve surgeons, and advanced imaging experts); but there were also several sessions in which physicians discussed how deeply this technology will/should penetrate US clinical practice over the next several months. Although TAVI offers a new treatment paradigm for valve disease patients, one that many believe could significantly expand the treatable patient population, there are still some important questions about this procedure that remain to be answered – such as whether TAVI’s higher stroke risk compared to valve replacement surgery will limit its usefulness outside of inoperable or high surgical risk patients, and how durable TAVI devices will prove to be over the long term.

While researchers strive to answer these questions, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need, particularly with regards to reducing the risk of the most vexing procedure-related complications, such as stroke and vascular access complications. More than a dozen early-stage companies have sprung up over the past several years to address these needs, and for good reason

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

23andMe Purchase Will Let Regeneron Scale Drug Development

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By 

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

More from North America

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By 

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.