Early results “encouraging” for Edwards’ redesigned Sapien XT valve

Edwards Lifesciences' Sapien and Sapien XT valves

Edwards Lifesciences’ original Sapien (left) and new Sapien XT (right) valves.

Medical device maker Edwards Lifesciences (NYSE:EW) unveiled results from the 1st randomized study of its Sapien XT transcatheter aortic valve replacement system, reporting non-significant improvements in safety when compared with the original Sapien system.

The PARTNER II trial’s Cohort B was designed to demonstrate that the Sapien XT was at least non-inferior to Sapien classic in terms of safety and efficacy in treating patients too sick to undergo open-heart surgery. The study was a win in that regard, with many of the short- and long-term outcomes of the devices falling along similar lines.

At 30 days all-cause mortality for the Sapien XT was 3.5%, compared to 5.1% for the original Sapien valve, according to Edwards. Although the findings missed the mark for statistical significance, it was a victory for the Sapien line.

"These are the lowest 30-day mortality results for transcatheter aortic valve replacement in any study using rigorous clinical trial methodology," co-principal investigator Dr. Martin Leon said in prepared remarks. "For these inoperable patients, the sickest of the sick, they’re surprisingly good."

Disabling stroke rates at 30 days were also low for both groups, at 3.2% for Sapien XT and 3% for Sapien, according to Leon’s presentation.

At 1 year, all-cause mortality increased to 22.5% for Sapien XT and 23.7% for Sapien. Disabling stroke rates rose to 4.5% for Sapien XT and 4.6% for Sapien.

The PARTNER II trial is the 1st clinical study of its kind assessing the next-generation Sapien XT valve. It’s also the only study to compare Sapient XT against its predecessor, the original Sapien valve. PARTNER II was launched in part to re-examine the high rates of adverse events seen among TAVI patients in the 1st PARTNER trial, in which researchers reported that patients undergoing TAVI had a nearly doubled risk of stroke 30 days after the procedure compared with patients who underwent open-heart surgery for valve replacement. In addition, previous reviewers noted that patients who received transcatheter valve replacement had "more frequent vascular complications."

The FDA’s Circulatory System Devices advisory panel and ultimately the FDA itself decided that the device’s benefits outweigh the risks and in November 2011 handed Edwards Lifesciences the 1st U.S. premarket approval for a TAVI system.

The original Sapien is made of cow tissues and polyester supported with a stainless steel mesh frame. The device is compressed into the end of a catheter, which is slightly wider than a pencil, and inserted into the femoral artery through an incision in the leg. A physician threads the catheter to the heart where the Sapien device is released and expanded using a balloon.

The redesigned Sapien XT features material changes to the stent frame, the valve leaflet and the catheter that aim to make the device thinner and smaller. Sapien XT is a 40% lower-profile system than Sapien classic, according to the study abstract.

"With the new device, we can treat patients who have smaller vessels with less injury and less trauma, and the valve positioning is more precise," Dr. Leon said. "Any time you get below 20 French in catheter size, that’s significant for patient safety."

RSS From Medical Design & Outsourcing

  • Teknor Apex to showcase wide range of PVC compounds for medical devices at Medtec China
    Building on its international leadership role as a supplier of medical-grade PVC compounds, Teknor Apex Company has developed flexible and rigid formulations that address the special needs of device manufacturers. The company will highlight these capabilities at Medtec China 2015. “Teknor Apex produces or markets medical-grade PVC compounds in China, Singapore, Europe, and the United […]
  • The Raspberry Pi eco-system goes interstellar with the new Raspberry Pi Sense HAT
    Newark element14 has globally launched the latest addition to the expanding ecosystem of Raspberry Pi accessories, the Raspberry Pi Sense HAT, as featured in the ‘Astro Pi’ space mission. The Sense HAT will enable enthusiasts to control the same hardware used in space. The Sense HAT attaches to the Raspberry Pi board, and can be […]
  • CommScope completes acquisition of TE Connectivity’s Telecom
    CommScope Holding Company, has completed its previously announced acquisition of TE Connectivity’s Telecom, Enterprise and Wireless businesses, a leader in fiber optic connectivity for wireline and wireless networks. The all-cash transaction, valued at approximately $3 billion, strengthens CommScope’s position as a leading communications infrastructure provider with deeper resources to meet the world’s growing demand for network […]
  • SPI awards IKO Prosthetic Creative System the Student Design International Design Excellence Award
    SPI: The Plastics Industry Trade Association congratulated IKO Prosthetic Creative System for winning the SPI Student Design Award, part of the Industrial Designers Society of America’s (IDSA’s) International Design Excellence Awards (IDEA) program. The award was presented to IKO, an innovative, youth-focused prosthetic design company led by Chicago-based designer Carlos Torres, by SPI’s Senior Director of […]
  • New assay could revolutionize diagnosis and treatment of life-threatening disease
    Invasive Fungal Disease (IFD) is an emerging global health problem associated with high mortality rates in severely immunocompromised patients, such as those undergoing intensive chemotherapy or stem cell transplantation, and in patients suffering immune compromising conditions such as AIDS. The most common causative agents of this disease have been identified as Candida and Aspergillus species, […]
  • Molex delivers ISO 13485-compliant, medical-grade surgical cables from its class 100,000 clean room facility
    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
  • RIVANNA commences manufacturing of its Accuro device
    Rivanna Medical announced that it has begun manufacturing its FDA-cleared Accuro device, a handheld and untethered smart-phone-sized device that is designed to guide spinal anesthesia with automated 3D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. The product will be launched at the ASA annual meeting in San […]
  • FDA seeks public input on Quality Metrics guidance
    by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation […]

Leave a Reply