News | Heart Valve Technology | September 22, 2016

4Tech Reports First Successful Implant of TriCinch Transcatheter Tricuspid Valve Repair Device

World’s first TTVR procedure without use of TEE or general anesthesia successful for high-risk surgical patient

4Tech, TriCinch TTVR, transcather tricuspid valve repair device, first implant

September 22, 2016 — 4Tech Inc. announced that its TriCinch device has been used in the world’s first-ever successful transcatheter tricuspid valve repair without the use of transesophageal echocardiography (TEE) or general anesthesia to successfully treat tricuspid regurgitation (TR). The TriCinch implant took less than one hour and allowed substantial reduction of TR.

The ongoing feasibility study is being conducted at San Raffaele Hospital and in other sites in Italy and in Europe. Investigators for the study include Azeem Latib, M.D., senior interventional cardiologist; Eustachio Agricola, M.D., senior echocardiographist; and Paolo Denti, M.D., hybrid cardiovascular surgeon.

“Our patient was at very high risk for surgical treatment, and she was referred to us by a cardiac surgeon,” said Agricola. “Equally critical, she was unable to undergo TEE because of an esophageal diverticulum and thus there were extremely limited options for offering her any treatment.”

“Fortunately, the extensive experience of the San Raffaele team with transcatheter treatment of the tricuspid valve and cardiac imaging allowed for the treatment,” added Latib. “The successful treatment of this case opens up new options for minimally invasive treatment of patients with FTR (functional tricuspid regurgitation).”

TR is a difficult-to-manage, age-related disease in which blood “backflows” into the right side of the heart. Today’s standard of care for TR is medical management. Surgical intervention is very high-risk. In-hospital death post-cardiac surgery for isolated TR can be as high as 37 percent. Unfortunately, TR patients tend to be non-compliant with their medications. Thus, TR and related complications induce substantial healthcare spending due to frequent re-hospitalizations. Furthermore, TR leads to chronic renal failure and end-stage dialysis. The combination of these negative outcomes results in a significant unmet need for an interventional cardiology solution to TR.

The 4Tech TriCinch System for Transcatheter Tricuspid Valve Repair is in the early phase of development. It will not be available in the United States for clinical trials until further notice and is not available for sale.

Watch the VIDEO "Transcatheter Tricuspid Valve Repair and Replacement Technologies," and discussion with Rebecca Hahn, M.D.

For more information: www.4techtricuspid.com

Related Content

Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
Overlay Init