See Ramed.com for FDA Indications
WATCH HOW THE DABRA ATHERECTOMY SYSTEM WORKS
The DABRA catheter is the first atherectomy device designed to be used without a guidewire. Most doctors question whether it's feasible until they try it and realize it works, and in fact is safer as it won't go subintimal.
Tracks True Lumen
The DABRA catheter tends to track the true lumen even while ablating tough calcified lesions without a guidewire in front.
The DABRA catheter is designed as a forward cutting device. It won't damage the vessel wall, which improves safety and prevents perforation and subintimal penetration.
The DABRA Catheter is a forward-cutter, designed to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. DABRA is a high fill-factor liquid filled 1.5mm catheter through which a non-thermal, emitted Excimer laser light molecularly ablates plaque, turning it into its own constituent components, not showering downstream debris. The wavelength of the emitted light is the result of a pulsed high-energy electrical current that is passed through a gas mixture in what’s called an Excimer laser. DABRA catheters are disposable and packaged in a standard endovascular pouch. The DABRA Atherectomy System laser lightsource is small enough for any treatment room, intuitive to use, and uses a standard 110-volt outlet. Treatments are reimbursed by Medicare and most insurance.
What Is An Excimer Laser?
An XeCl laser that emits pulses of ultraviolet light at 308 nm.
The DABRA Atherectomy System accommodates a DABRA catheter to deliver the laser energy to the arterial blockage. Operating parameter ranges for this excimer laser system are fluence between 8 and 15mJ/mm2 and pulse repetition rates between 20 and 80 pulses per second. Excimer a contraction of "excited dimer." Excimer lasers are a class of gas-discharge lasers, in which pulsed high energy electrical current is passed through a gas mixture. In excimer lasers, the mixture contains a rare gas (Ar, Kr, or Xe) and a halogen (Cl or F).The wavelength of the emitted light is determined by which rare gas-halogen pair are in the mixture.Most excimer lasers emit in the ultraviolet region, generally between 350 and 193 nm.
Excimer Laser Development
From 1975-1979 many scientists and institutions worked on the initial development of a family of gas lasers known as the "excimer."
Those pioneers were with institutions including Lumonics, Lambda Physik, Avco, and Caltech. The development was initiated in part because of the short wavelength of this type of light source. Monochromatic short wavelength sources were thought to have a variety of commercial and military applications.
The name excimer is a contraction of "excited dimer," a description of a 20- 4 diatomic molecule in which the component atoms are bound in the excited state, but not in the ground state. The important gas molecules are rare gas halides including argon fluoride, krypton fluoride, and xenon chloride. The ultraviolet light from an excimer laser is well absorbed by biological matter and organic compounds. Rather than burning or cutting material, the excimer laser adds enough energy to disrupt the molecular bonds of the surface tissue, which effectively disintegrates in a tightly controlled manner through ablation rather than burning. Thus excimer lasers have the useful property that they can remove exceptionally fine layers of surface material with almost no heating or change to the remainder of the material which is left intact. These properties make excimer lasers well suited to precision micromachining organic material, or delicate surgeries such as eye surgery. At lower energy densities, the laser may also be used for dermatological disorder treatment. Excimer laser light is typically absorbed within the first billionth of a meter (nanometer) of tissue.
In the early 1980s, researchers at IBM’s T. J. Watson Research Center observed the effect of the ultraviolet excimer laser on biological materials. They found that the laser made clean precise cuts that would be ideal for delicate surgeries. Subsequent work introduced the excimer laser for use in angioplasty or atherectomy, destroying blockages in arteries using molecular ablation. Xenon chloride excimer lasers, having a wavelength of 308nm, can also treat a variety of dermatological conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Excimer Laser Atherectomy
In the late 1980s, 308nm excimer laser atherectomy was developed as an alternative method of percutaneous angioplasty, with the objective of reducing the high rate of restenosis associated with other angioplasty or stenting techniques.
Excimer laser atherectomy is a procedure that utilizes an intravascular catheter system to deliver high-energy pulsed laser light to atherosclerotic lesions, or plaque, that are causing stenosis or occlusion of native arteries, or intra-arterial stents, while producing relatively little thermal damage to the vessel wall. The pulses ablate thin sections of tissue without causing significant damage to surrounding tissue. It is thought that reduction of plaque using laser ablation could be more effective in enlarging the vessel lumen than balloon angioplasty alone. Early data from large observational registry studies published in the early 1990s provided evidence of the safety of the procedure.
By 1994, Advanced Interventional Systems (AIS) had commercialized a system and gained FDA approval for the procedure. Later in the decade AIS merged with Spectranetics, Inc., which had developed an excimer for treating peripherals. There are approximately 1,000 Spectranetics lasers placed today, and thousands of excimer laser endovascular procedures are performed each year. The Ra Medical team, which includes members of the Spectranetics and AIS development teams, began developing the DABRA Atherectomy System, including the excimer laser and DABRA Catheter for crossing lesions in 2006.
150cm working length, full-fill factor, liquid-filled catheter
14”W x 27”L x 32”H (36cm x 68cm x 82cm)
120/230 VAC, 50/60Hz, 6/3A
Doctors participating in Ra Medical's FDA study share their view
Doctors talk about some of their most successful cases using the DABRA Atherectomy System
The Story Behind DABRA "Jumping" From TP Trunk To Peroneal
Ra Medical Systems Clinical Specialist
Watch DABRA "Jump" From TP Trunk To Peroneal
Featured Case: World's FIRST DABRA In-Stent Restenosis Case
Marzia Lugli, MD
In a series of “firsts,” Dr. Marzia Lugli performs the first DABRA In-Stent Restenosis case, in the first venous case for the DABRA Atherectomy System, in its first commercial use outside of a clinical study, in its first case in Europe. This successful case was Dr Lugli’s first time using the DABRA and she is the first female physician to use the DABRA in the world.
Featured Case: Anterior Tibeal Artery
Flavio Airoldi, MD
Watch as the DABRA Catheter follows the true lumen of the Anterior Tibial Artery. This was Dr. Flavio Airoldi's second case using the DABRA Atherectomy System.
Athar Ansari, MD, FACC
California Heart & Vascular Clinic
This case demonstrates how quickly and effectively the DABRA catheter works for a CTO.
Ehtisham Mahmud, MD, FACC, FSCAII
UC San Diego Cardiovascular Clinic
Dr. Mahmud explains how the DABRA catheter tends to track the true lumen in one of the most successful cases performed at UCSD during the Ra Medical FDA study.
Ernesto Rodriguera, MD, FACC
Excel Medical Center
Dr. Rodriguera was one of the first doctors to use the DABRA Atherectomy System. He's performed 15 cases as part of the FDA study. Case 31 was one of the toughest cases yet.
Photos of CTO cases in which doctors couldn't cross with a guidewire.
Interventional Cardiologists who participated in the DABRA Atherectomy System FDA study share their experience and the potential they see for the future.
Raghotham Patlola, MD, FACC, FSCAI
Dr. Patlola presented FDA results of DABRA Laser System at C3 conference in Orlando, Florida on June 29, 2017.
Raghotham Patlola, MD, FACC, FSCAI
Wesley Medical Center, Hattiesburg, Mississippi
Athar Ansari, MD, FACC
California Heart & Vascular Clinic, El Centro, California
Ehtisham Mahmud, MD, FACC, FSCAI
UC San Diego Health System's Chief of Cardiovascular Medicine
Mitul Patel, MD, FACC, FSCAI
UC San Diego Health System
Some of the very first patients share what their life was like before getting treated using the DABRA Atherectomy System, and how their life has changed dramatically one year following treatment.
50-Year-Old Female Patient
Excel Medical Center, Tijuana, Mexico
Dr. Ernesto Rodriguera crossed a 10-12cm CTO in the right SFA using the DABRA Atherectomy System. The patient remains patent one year after treatment.
84-Year-Old Male Patient
Excel Medical Center, Tijuana, Mexico
Doctors had performed a femoral popliteal bypass, but it reoccluded and so this patient was referred to Dr. Ernesto Rodriguera, who successfully used the DABRA Atherectomy System. The patient remains patent one year after treatment.
68-Year-Old Male Patient
California Heart & Vascular Clinic, El Centro, CA
A doctor at a large hospital told this man he would never play tennis again. He had been walking with a can for more than a month when he approached Dr. Athar Ansari for a second opinion. Dr. Ansari used the DABRA Laser System to unclog his popliteal artery, and he was back on the tennis court three days later. One week later, journalist Kym McNicholas rallied against him and had him running for the ball.
Ra Medical Systems is currently partnered with distributors in the Netherlands and Italy.
BeNaLux and Scandanavia
bo medical technologies engages in exclusive distribution and sales of cosmedical technology. We look at cosmetic care from a medical perspective and seek products whose effects are beyond dispute and published in leading medical journals. The portfolio consists of breakthrough devices and products for dermatologists and plastic surgeons. For more information about the DABRA Atherectomy System, contact: email@example.com
The company was founded in 2000 from the entrepreneurial spirit of Mr. Franco Papa, who holds the position of CEO since the initial constitution and puts at the service of the Company his ability gained in the medical field since the early ’90s. For more information about the DABRA Atherectomy System,
contact: +39 0322 772032
OEIS Annual Meeting
March 31 - April 1, 2017
We have a booth at the show. Plus, Dr. Athar Ansari with California Heart & Vascular clinic talks about the clinical outcomes of cases he performed during Ra Medical System's FDA Study. Here's the link to the show's site: OEIS Annual Meeting
May 10-13, 2017
Come visit our booth at this year's show! We'll have the DABRA Atherectomy System on display. Plus, check out videos of actual cases during Ra Medical's FDA study, where you can watch the DABRA laser ablate through plaque real-time. Here's the link: SCAI 2017
NCVH Annual Conference
May 31-June 2, 2017
Come visit our booth at this year's show! We'll have the DABRA Atherectomy System on display. Plus, check out videos of actual cases during Ra Medical's FDA study. Here's the link: NCVH Annual Conference