Today St. Jude announced that its first controlled study of Deep Brain Stimulation (DBS) confirms benefit of constant current system for patients with Parkinson’s Disease.
Results were published online today by The Lancet Neurology journal. The aim of the study was to evaluate the Libra(TM) and LibraXP(TM) DBS constant current systems to determine the devices’ safety and effectiveness in managing the symptoms of PD. Continue reading
Yesterday, Jan 9, 2011, St. Jude Medical announced preliminary revenue results for the fourth quarter ended December 31, 2011:
“Fourth quarter cardiac rhythm management sales were approximately $728 million, a 4 percent decrease compared with the fourth quarter of 2010. Fourth quarter sales of implantable cardiac defibrillators were approximately $436 million, a 5 percent decrease from the comparable quarter in 2010. Pacemaker sales during the quarter were approximately $292 million, a 4 percent decrease compared with the fourth quarter of 2010.
…
Fourth quarter sales of neuromodulation products were approximately $121 million, a 12 percent increase compared to the fourth quarter of 2010.”
Company website: www.sjm.com
The Cardio Care II Pacemaker was American Optical’s second implantable device. It was an improved version of the Cardio Care pacemaker. Besides improvements to the circuitry, the circuit board was enclosed separately inside a hermetic can within the epoxy encapsulation. Continue reading
Barouh Berkovits at American Optical Co of Boston, MA designed the first “Demand Pacemaker” – what we now know as a VVI pacemaker. The Cardio-Care Demand Pacemaker, introduced in 1968, was American Optical’s first implantable device.
From Kirk Jeffrey’s Machines in our Hearts(2001):
“Berkovits in 1963 designed a sensing capability into the pacemaker. His invention behaved exactly like an asynchronous pacer until it detected a naturally occurring R wave, the indication of a ventricular contraction. This event would reset the timing circuit of the pacemaker, and the countdown to the next stimulus would begin anew. Thus the pacer stimulated the heart only when the ventricles failed to contract. It worked only ‘‘on demand.’’ As an added benefit, noncompetitive pacing extended the life of the battery. Continue reading
I took this picture a very long time ago at the office of one of my implanter friends in Europe. Ever since then, I’ve tried to find out about “Digikon,” but have had no luck so far. All that I have been able to find from the St. Jude legacy device database is that Digikon had produced a number of pacemaker models, including the one shown in this picture.
In 1983, Bill Cook and Dr. Neal Fearnot began to work under the Cook Pacemaker Company in Leechburg, PA on developing the technology developed by Dr. Fearnot at Purdue University into an improved prototype for a temperature-based exercise responsive pacemaker that was released in 1988 as the Kelvin Sensor rate-responsive pacemaker. One of the first CVT rate-adaptive pacemakers was the Cook Model Kelvin 500 series. Continue reading
The Circadia pacemaker was one of the very few devices that had a lead-borne thermistor to measure cental venous temperature (CVT) as a sensor for rate-response.
A unique feature of this pacemaker was an iridium-oxide (IrOx)-coated button welded to the can. It was believed that this button would improve unipolar IEGM sensing and reduce unipolar pacing thresholds (it didn’t). Continue reading
One of the indicators of metabolic demand that has been used for controlling the rate of pacemakers is central venous blood temperature (CVT).
In 1983, Bill Cook and Dr. Neal Fearnot began to work under the Cook Pacemaker Company on developing the technology developed by Dr. Fearnot at Purdue University into an improved prototype for a temperature-based exercise responsive pacemaker that was released in 1988 as the Kelvin Sensor rate-responsive pacemaker. One of the first CVT rate-adaptive pacemakers was the Cook Model Kelvin 500 series.
Another one of the first CVT rate-adaptive pacemakers was the Intermedics Nova MR, which differs from the Kelvin 500 series in that its pacing algorithm had a more dynamic HR response. Continue reading
The Medtronic Chronicle implantable hemodynamic monitor used a specialized RV lead/sensor. The device was able to monitor and telemeter:
Medcor was established in Hollywood, FL in 1969, and began developing pacemakers, lead and accessories in 1971. By 1975 it had a series of lithium-powered pacemaker in the market, but they never became popular with physicians.
On July 1980, Daig Corporation of Minnetonka, MN acquired Medcor with the expectation that Medcor pacemaker technology could be profitably marketed.
Daig had hoped to market a new line of Medcor pacemakers, but significant electronic malfunctions were encountered which foreclosed further development Medcor’s pacemaker product line. As a result of malfunctions in the first pacemaker line, FDA approval was withheld on a second Medcor line of pacemakers due to similarities in product design.
In 1981, amidst a very serious financial condition, Daig closed its doors. The remaining assets were acquired by Daig’s largest customer – Pacesetter (now part of St. Jude Medical).
UPDATE, May 20, 2013:
Mark Christensen – who worked at Daig Corporation from 1980 to 1986 – sent me a kind note with some additional information: “As you note in your comments on Medcor, it was purchased by Daig in 1980 but remained as a separate business. Daig’s financial crisis in 1981 caused Daig to go into Chapter 11 Bankruptcy and Medcor went to Chapter 7 – liquidation and was sold at auction in late 1981. No pacemaker company bought any of the assets. Daig reorganized, diversified into EP catheters and was bought by St Jude Medical in 1996 (15 years later).” Thanks Mark!
Image Credit: VeriMed
VeriMed’s VeriChip is the only RFID tag that has been cleared by FDA for human implant. The concept behind the medical use of the VeriChip is that patients would have the tiny chip implanted just under the skin, in the back of the arm. Each VeriMed microchip contains a unique identification number that emergency personnel may scan to immediately identify the patient and access his/her personal health information, thus facilitating appropriate treatment without delay. This is especially important for patients who suffer from conditions that may render them unconscious, confused, or unable to communicate. Although the FDA approved the use of the device for anyone 12 years of age or older, it would mostly be recommended for patients with diabetes, stroke, seizure disorders, dementia, Alzheimer’s, developmental disorders, and organ transplants.
CardioMEMS was founded by Dr. Jay S. Yadav and Dr. Mark G. Allen in Atlanta, GA in 2000 to develop implantable micro-electromechanical sensors to improve the management of severe chronic cardiovascular diseases such as heart failure and aneurysms.
The miniature wireless sensors can be delivered through a catheter. Once in place, they transmit cardiac output, blood pressure and heart rate data that are critical to the management of patients. Due to their small size, durability, and lack of wires and batteries, CardioMEMS’ sensors are designed to be permanently implanted into the cardiovascular system. An external reader is used to interrogate the sensors. Continue reading
NDI Medical was founded in 2002 by Geoffrey B. Thrope to develop and commercialize neurodevice products. NDI Medical developed the MicroPulse neurostimulator, a thumb-sized, rechargeable pulse generator, that has been used for the treatment of incontinence and pain, as well as an implantable device for the restoration of function of paralyzed limbs.
According to a 2006 news release by the electronics assembly manufacturer for the MicroPulse:
“Using minimally-invasive surgery, the Micropulse is implanted into a patient, usually in the lower abdomen or buttock, where the device is most comfortable and least visible. After implantation, a clinician uses a wireless programmer to set the Micropulse’s stimulus parameter and timing patterns. The programmer, as well as the patient’s controller for the device, has a range of about three feet.
To recharge the device’s lithium-ion battery, the patient applies a recharging patch for several hours to the vicinity of the implant. The battery needs recharging from once a month to every few weeks.” Continue reading
Leptos Biomedical was founded in Fridley, MN in 2002 by Dr. John D. Dobak. Leptos intended to develop an implantable device to stimulate the greater splanchnic nerve, that was hoped would result in reduced food intake and increased energy expenditure.
In February 2010 Leptos announced its closure. Reasons were not provided, but it has been suggested that the decision was prompted by the 2009 announcement by competitor EnteroMedics’ that it had failed to meet the primary goals of its pivotal study. EnteroMedics’ Maestro device didn’t perform any better than a sham device. EnteroMedics is now conducting a new study with the device.
Click here for Leptos Biomedical’s patents.
Palyon Medical Corporation was founded in 2004 in New York, NY, but recently moved its operations to Santa Clarita, CA. Palyon is still operating stealthily.
Palyon is developing a programmable implantable drug delivery system (IDDS) which delivers targeted doses of pain medication directly to the spinal area for the treatment of chronic pain, spasticity and other neurological diseases. According to Luis Malave, the company’s CEO, “Due to its inherent flexibility as a delivery platform, the IDDS can be used to deliver therapeutics to treat both acute diseases, such as cancer, and chronic diseases including diabetes and multiple sclerosis.” Continue reading