A blog about what is new (and old) in the world of active implantable medical devices

Monthly Archives: February 2014

Submitting AIMD System Applications to China’s State FDA

Posted on by Posted in AIMD Business, My Portfolio, Tech Talk

Beijing Institute of Medical Device Testing David Prutchi Ph.D. www.implantable-devices.com

I just came back from Beijing where we are in the process of registering our AIMD systems.  The process if very different than submitting an application to a EU Notified Body or to FDA.  This is because China’s State FDA (S-FDA) doesn’t accept testing performed abroad.  S-FDA only accepts testing performed at one of the Chinese nationally-recognized test labs, so it doesn’t matter how or who did your testing outside of China, your devices must be retested by one of the Chinese NRTLs to applicable standards.

Beijing Institute of Medical Device Testing David Prutchi Ph.D. www.implantable-devices.com

We are performing our testing at the Beijing Institute of Medical Devices (BIMT) – a World-Class testing laboratory equipped with the very latest test equipment (including beautiful, new 10m and 30m EMC chambers brought from France, and equipped with top-of-the-line equipment by Rohde&Schwarz, Tektronix, Agilent, etc.).  Most importantly, I found their engineers to be very knowledgeable and kind.  It was a really pleasant experience!

BIMT EMC Chambers David Prutchi PhD

 PS.  My photos of Beijing are at: http://www.flickr.com/photos/prutchi/sets/72157640189751133/

 

SecondSight Starts US Commercial Implants of Argus II Retinal Prosthesis

Posted on by Posted in Blindness, Retinal Stimulation, retinitis pigmentosa, Second Sight

Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center.  Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa.

 

St. Jude Implants First US Patient with its Nanostim Leadless Cardiac Pacemaker

Posted on by Posted in Cardiac Pacing, Nanostim, St. Jude Medical

IMAGE_Nanostim_Product_Shot[1]

St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.  The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical research trial designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device. It is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at 50 centers in the U.S., Canada and Europe.

According to the press release:

The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

Continue reading→

St. Jude Medical Announces Q4 2013 Results: CRM Up 4%, Neuromodulation Up 2%

Posted on by Posted in AIMD Business, St. Jude Medical

logo_StJudeMedical

St Jude Medical announced that its Cardiac Rhythm Management sales increased 5 percent on a constant-currency basis over the fourth quarter of 2012.  Neuromodulation sales for the same period increased by 2%.  According to the press release:

Cardiac Rhythm Management

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $705 million for the fourth quarter of 2013, a 3 percent increase compared with the fourth quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales increased 5 percent. Total CRM product sales for the full-year 2013 were $2.783 billion, down approximately 2 percent from 2012. On a constant-currency basis, total CRM sales declined 1 percent from the prior year.

Of that total, ICD product sales were $442 million in the fourth quarter, a 5 percent increase on a reported and constant-currency basis compared with the fourth quarter of 2012. ICD product sales for the full-year 2013 were $1.741 billion, flat when compared with 2012. On a constant-currency basis, total ICD sales increased 1 percent over the prior year.

Fourth quarter pacemaker sales were $263 million, a 1 percent increase compared with the fourth quarter of 2012. On a constant-currency basis, pacemaker product sales increased 4 percent in the fourth quarter. Total pacemaker sales for 2013 were $1.042 billion, down 6 percent compared with pacemaker sales in 2012. On a constant-currency basis, total pacemaker sales declined 4 percent from the prior year.

Neuromodulation

St. Jude Medical sales of neuromodulation products were $115 million in the fourth quarter of 2013, a 2 percent increase on a reported and constant-currency basis over the prior year. Total neuromodulation product sales for 2013 were $426 million, a 1 percent increase over 2012 sales.

 

 

Reveal LINQ: Medtronic’s New Miniaturized Insertable Cardiac Monitoring System

Posted on by Posted in ECG Monitoring, Medtronic

Medtronic Reveal LINQ David Prutchi PhD www.implantable-device.com

Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder.  The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller!

 The Reveal LINQ is a leadless device that is implanted in the region of the thorax by way of a <1cm incision. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias.

 Reveal LINQ stores a total of 57 minutes of ECG, including 27 minutes of automatically-detected episodes and up to 30 minutes of patient-activated recordings with 6.5–14 min. buffers.

The device connects wirelessly with Medtronic’s MyCareLink™ Patient Monitor, making the Reveal LINQ ICM the only ICM to collect and trend data continuously and wirelessly.

httpv://youtu.be/aKJkyttF3iA