Navigation Links
PMDA Approves Jarvik 2000 Heart in Japan
Date:12/5/2013

NEW YORK, Dec. 5, 2013 /PRNewswire/ -- JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval to the Shonin (or pre-market approval) application submitted by Century Medical, Inc., (CMI) for the Jarvik 2000 Heart, a small Left Ventricular Assist Device (LVAD) implanted inside the natural heart. CMI is the exclusive distributor of the Jarvik 2000 in Japan. Shonin approval was granted on November 22, 2013, following the PMDA's review of data on Japanese and U.S. clinical trials with the device. In Japan, where there is an extended waiting time for donors, patients have been supported long term by the Jarvik 2000, for up to four years, and then have been successfully transplanted  once a donor heart has become available.

The Jarvik 2000, manufactured in New York by Jarvik Heart, Inc., is the smallest LVAD approved for long-term use in Japan. At only 30cc volume and 90 grams (about the size of a C-cell battery), the Jarvik 2000 can support the hearts of patients only 4' 6" tall and weighing less than 85 lbs. Yet the same blood pump can also support large patients more than 6' 2" tall and weighing more than 225 lbs. For smaller patients, the pump is operated at slower speeds; for larger patients, it is operated at higher speeds.

In Europe, the Jarvik 2000 Heart has CE mark approval. In the U.S., Jarvik Heart has completed a 150-patient Pivotal Trial for Bridge to Transplant. A randomized trial (with comparison to the HeartMate II) for long-term use is currently in progress. More than 300 patients will be evaluated for survival two years after implant and for absence of infection at three years. 

More than 600 patients at dozens of hospitals in twelve countries have been treated for severe heart failure with the Jarvik 2000. Many patients have been transplanted or supported long term with an excellent quality of life. Today (Dec. 5th), a patient in France celebrates his eighth year of active life supported by the Jarvik 2000. The very first patient to receive the Jarvik 2000 as a bridge to a transplant is doing well thirteen years after implantation of her donor heart.

Jarvik Heart, Inc. is also developing a miniature Jarvik 2000 for use in infants. This work is supported by the National Heart, Lung, and Blood Institute (NHLBI) under the PumpKIN program (Pumps for Kids, Infants, and Neonates). Initiation of a multicenter clinical trial is planned for 2014.

For more information, please visit jarvikheart.com and cmi.co.jp.


'/>"/>
SOURCE Jarvik Heart, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Novogen Board Approves US$4 Million Investment In Marshall Edwards Rights Offering
2. FDA Approves NDA Supported By MedAvante Central Ratings
3. Cardinal Health Board Of Directors Approves Cash Dividend; Authorizes New $750 Million Share Repurchase Program
4. FDA Approves Neuralstem To Treat Final Cohort In NSI-189 Phase Ib Trial In Major Depressive Disorder
5. Specialty Pharmacy Certification Board (SPCB) Approves Content for Certified Specialty Pharmacist (CSP) Certification Exam
6. FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGICS PANTHER SYSTEM
7. FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults
8. FDA approves drug tested by Scottsdale Healthcare and TGen
9. FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologics Panther System
10. HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
11. Retired Pro Hockey Player 1st to Receive Total Artificial Heart in Upstate New York
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
(Date:10/2/2017)... Lilly and Company (NYSE: LLY ) will ... 2017 on Tuesday, October 24, 2017. Lilly will also ... investment community and media to further detail the company,s ... at 9 a.m. Eastern time. Investors, media and the ... conference call through a link that will be posted ...
(Date:9/28/2017)... -- Cohen Veterans Bioscience and Early Signal Foundation announce ... home sensors for real-time monitoring of patients with trauma-related ... organization focused on disruptive health solutions for rare disorders ... to record and integrate behavioral, cognitive, physiological and contextual ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... PurhealthRX , a leading Health and Nutrition Company, is announcing ... full spectrum CBD oil will revolutionize the rapidly growing CBD market by reducing the ... incorporated into liquid products, while reducing costs to end users. , The team of ...
(Date:10/13/2017)... CT (PRWEB) , ... October 13, 2017 , ... ... long-term care services, staged a mock evacuation of the facility as part of a ... Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as ...
(Date:10/13/2017)... ... 13, 2017 , ... Ellevate Network, the leading network for professional women, brought ... gender equality at their inaugural Summit in New York City in June. The event ... audience of over 3 million. To watch the Mobilize Women video, click here ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob ... sciatica in a new episode of "Success Files," which is an award-winning educational ... and investigates each subject in-depth with passion and integrity. , Sciatica occurs when ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
Breaking Medicine News(10 mins):