1. Medtech Insight
  2. >>Business
  3. >>Strategy

Edwards Reveals Sapien Launch Plans For Transapical Delivery Method

Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical, through the ribcage, route.

Edwards Lifesciences Corp. plans to rapidly train heart teams over the next two quarters to support the transapical delivery of its Sapien transcatheter heart valve following the recent expanded approval by FDA.

The device gained PMA approval on Oct. 19 for use in patients with aortic valve stenosis who are eligible for...

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
Start Free Trial

Already a subscriber?

More from Strategy

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 
• By Natasha Barrow

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

Intuitive Surgical Projects $165M Tariff Hit In 2025, Says Wait-And-See On Mitigation

 
• By Shubham Singh

Despite near-term cost pressures, Intuitive Surgical is expanding manufacturing and R&D in North America and Europe to meet demand for Ion, X and Xi systems.

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Thermo Fisher Cuts Annual Profit Outlook Amid Estimated $400M Tariff Hit

 
• By Shubham Singh

Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.

More from Business

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Thermo Fisher Cuts Annual Profit Outlook Amid Estimated $400M Tariff Hit

 
• By Shubham Singh

Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.