TAVI Halo Shines On Embolic Protection Devices

Transcatheter heart valve (TAVI) companies are hot. A market that was worth $20-$30 million just two or three years ago, based on devices with an average selling price of $23,000, was worth more than $400 million in 2010, and to date these products are only approved in Europe. A major stumbling block to widespread penetration exists however: the higher risk of stroke seen with TAVI as compared to surgical valve replacement. Thus, investors are spreading the net out further, to scoop up companies developing embolic protection devices, to solve some of the potential neuro problems that can result from TAVI.

Large acquiring device companies, in recent years, have increasingly adopted a "show me" attitude toward innovative device start-ups, requiring the small companies to minimize as much risk as possible by validating their products and markets, even going so far in some cases as to look for significant revenues before taking them into the fold. There is a notable exception in structural heart disease, however, where strategic acquirers have shown their willingness to pay up for companies in the transcatheter aortic heart valve segment before these start-ups have even gained FDA approval.

Edwards Lifesciences Corp. was the first to employ this strategy in 2003, buying Percutaneous Valve Technologies early in its...

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 Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By 

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By 

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By 

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.